Manager, Regulatory Compliance Resume Sample
Antonette Greenholt
926 Kerluke Canyon,
Chicago,
IL
+1 (555) 823 5202
Work Experience
Manager, Regulatory Compliance
12/2016
-
PRESENT
Los Angeles, CA
- Manages Risk and Compliance Business Office (RCBO) initiatives for assigned area in Risk & Compliance including but not limited to: complex problem-solving, business continuity, and developing processes
- Develops financial analysis, modeling, and reporting to support business results tracking and decision-making
- Conducts qualitative and quantitative analysis and prepares metrics on assigned business areas to include forecasts, incentives, budgets and/or cost-benefit analyses
- Manages vendor Statement of Work (SoW), invoices, and tracking of project expenses
- Helps to ensure Risk & Compliance functions are operated “as a business”, by managing costs and headcount efficiently and effectively
- Identification of Regulatory compliance changes and potential impacts on Global Functions and HTS Business Models in region
- Implementation of global standards and strategic policies which ensure Global Function’s & HTS’ exposure to current risks and emerging arising risk is managed appropriately
- As needed, provides regulatory disclosures expertise to cross-functional teams and other groups
- As needed or otherwise appropriate, participates in periodic RAFT meetings. Including providing expertise regarding regulatory disclosures processes, compliance, timelines, maintenance and other relevant matters
Manager Regulatory Compliance
01/2012
-
08/2016
Phoenix, AZ
- Contributes to development and maintenance of policies and/or Standard Operating Procedures (SOPs) on clinical trial registry and clinical trial results database processes
- Identifies studies required for registry and results postings, including applicable trials for results postings on relevant external websites. Ensures that responsible PDR management and staff are aware of timelines, deadlines and other requirements
- Tracks missing/late registry entries and Clinical Study Reports (CSRs) and liaises with PDR teams regarding dates of new product or line extension approvals
- Liaises with project teams and affiliates to ensure they understand their responsibilities in relation to regulatory documentation disclosures
- Submits protocol documents for preparation of registry entry and for quality control checks, i.e., consistency between registry and protocol, cross-protocol and franchise consistency. Similarly submits CSR document for preparation of results entries
- Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites
- Monitors workflows for registry and results entries to ensure timely and on-target completion
Regulatory Planning & Compliance Manager
10/2004
-
09/2011
Philadelphia, PA
- Completes document and data uploads in applicable systems
- Ensures protocol information is included in the registry as soon as the study design is finalized and first ethical/regulatory approval is received
- Ensures that study results are uploaded into results databases within applicable timeframes
- Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures appropriate responses are provided in a timely manner
- Reviews and assesses area(s) of responsibility in the U.S. Compliance Functions in accordance with the planned review schedule
- Coordinates administrative aspects of conducting a functional review (e.g., scheduling, sending out request lists, tracking information received, etc.)
- Completes workplan and prepares workpapers supporting work performed
- Supports the preparation and issuance of reports for each functional review
Education
George Fox University - Boise Center
1999 - 2003
Bachelor's Degree in Business
Professional Skills
- Excellent interpersonal skills and ability to develop strong relationships with business partners, senior management and compliance/legal colleagues
- Excellent communication and collaboration skills; and the ability to stay current on developing regulatory requirements are necessary as well
- Possesses strong judgment, confidence, collaborative problem solving skills, and the ability to spot potential issues quickly
- Self-starter with excellent organizational and communication skills
- Experience in problem resolution and impact assessment with strong analytical skill to dissect complex issues
- Analytical skills and technical RA knowledge (ability to assess impact of CMC variation or Label change on current situation)
- Understanding of the pharmaceutical industry and experience in drug development and/or marketed products
How to write Manager, Regulatory Compliance Resume
Manager, Regulatory Compliance role is responsible for analytical, collaboration, leadership, compliance, research, database, regulatory, planning, purchasing, trading.
To write great resume for manager, regulatory compliance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Regulatory Compliance Resume
The section contact information is important in your manager, regulatory compliance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Manager, Regulatory Compliance Resume
The section work experience is an essential part of your manager, regulatory compliance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manager, regulatory compliance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, regulatory compliance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Regulatory Compliance resume experience can include:
- Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision making skills
- Experience in working validation of ERP (SAP) and COTS application. Working on SaaS System Validation is desirable
- Strategic thinker as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills
- Strong skills in interdependent partnering to facilitate collaboration is required
- Possess excellent communication, management, and decision making skills
- Strong IT skills (Microsoft applications - Word, Excel, PowerPoint, Access) are desirable
Education on a Manager, Regulatory Compliance Resume
Make sure to make education a priority on your manager, regulatory compliance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, regulatory compliance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Manager, Regulatory Compliance Resume
When listing skills on your manager, regulatory compliance resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical manager, regulatory compliance skills:
- Achievement oriented with excellent written and oral communication skills
- Strong ability in reviewing and assessing regulatory requirements and business impact analysis
- Proven ability to communicate with all levels of staff, including dealing with conflict and diverse opinions
- Strong understanding of compliance obligations, emerging changes, issues and opportunities in financial services
- Excellent knowledge and understanding of rules and regulations applicable to trusts, registered plans and pensions
- Valid driver license and current passport required
List of Typical Experience For a Manager, Regulatory Compliance Resume
1
Experience For Manager Regulatory Compliance Resume
- Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups
- Demonstrated compliance experience in domestic and international medical device, pharmaceutical and combination product quality systems
- Operates in a competitive, complex, and rapidly changing environment
- Provide guidance on revising validation documents and protocols
- Experience in CSV auditing and inspections against regulatory and benchmark quality standards
- Ensure effective inspection readiness at DePuy franchise and manufacturing site
- Partner with global business in ensuring effective inspection readiness approaches are defined and executed against
- Experience with progressive quality systems, quality control, quality assurance, including hands on advanced quality systems compliance is required
- Experience managing in a direct and matrixed environment
2
Experience For Senior Manager OTC Consumer Regulatory Compliance Resume
- Able to build strong, open and collaborative working relationships with both internal and external stakeholders
- Defines operational priorities and tactics
- Resolves conflicts in priorities in consultation with supervisor and internal customers
- Experience working in a legal or compliance role, preferably in house
- Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met
- Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs)
- Provide support to external and internal audits related to computerized system validation activities
- Direct managerial experience
3
Experience For Regulatory Planning & Compliance Manager Resume
- Work on multiple projects concurrently and prioritize resources
- Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization
- Proven ability to develop, present and justify positions to all levels within the company
- Results driven with a strong customer and quality focus
- Collaborate with functional department to establish effective corrective and preventive actions
- Direct experience with FDA inspections in a leadership role, is required
- Authoring and /or revising SOPs
- Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external)
- Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions
4
Experience For Manager, Regulatory Compliance Management Resume
- Specific areas of responsibility include: producing and managing regulatory compliance sharepoints, intranet, and reporting
- Independence on decision-making regarding regional strategies with supervisor approval
- Identify, analyze, and track delivery metrics to support leadership and engagement teams in decision-making, action planning, and continuous improvement
- Implements policies, procedures, and training programs; maintains the accuracy of policies, procedures and training programs against regulatory changes
- Responsible for performing performance evaluations of all AMS specialists and giving feedback to the station manager
- Makes informed decisions by soliciting input from others where needed
- Determines the organization’s current and ongoing compliance with Joint Commission/regulatory standards and provides/coordinates education
- Promotes culture of continual survey readiness, acting as a resource for leaders and staff
- Provides a mechanism which supports and monitors compliance with the Missouri Statutes governing patient rights and grievances
5
Experience For Manager, Regulatory Compliance Testing Resume
- Participates in and provides input for succession planning
- Coordination of similar applications occurring simultaneously across APAC, to ensure that key regulatory reviews are shared to avoid duplication of effort
- Manage a number of simultaneous tasks while demonstrating the ability to drive tasks and issues to completion
- Define and manage project scope, deliverables, budget, schedule, dependencies, service levels, other required operating metrics and scope
- Devise strategy and prepare sometimes complex submissions addressing regulatory compliance matters
- Organizes and leads problem solving teams to deal with and eliminate regulatory and compliance problems
- Assists in the preparation of responses to formal inquiries from governmental entities pertaining to Tech Data's activities
- Front line management of a staff of 5-6 employees including a remote employee
6
Experience For Manager, Regulatory & Compliance Resume
- Manage portfolio of regulatory supervisory activities including examinations, reviews/visits and central point of contacts (CPC) meetings
- Review and prepare concise, well-written communications, including final deliverables
- Provides management with continuous feedback and recommendations regarding risk mitigation
- Ensure that stations are operating efficiently within the regulatory framework
- Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations
- Areas of specific responsibility to include compliance matters relating to: Global Service Centres
- Provides input to department strategic objectives, goals and performance measures
7
Experience For Regulatory Compliance Risk Manager Resume
- Identify and act on process optimization opportunities
- Makes complex decisions in situations with multiple, ambiguous objectives and constraints
- Facilitates and participates in Regulatory Readiness related committees
- Supports with pre-survey and on-site and post survey activities
- Participate in new employee orientation and other leader education initiatives
8
Experience For Regulatory Compliance & Environmental Manager Resume
- Participate and attend annual regulatory conference(s)
- Provides direct supervision of the Patient Relations Coordinator
- Leads tracer activities throughout the facility to ensure a culture of ongoing regulatory readiness. Creates action plans to improve performance based on tracer outcomes
- Reports/participates in Quality Steering Committee, EOC, and other committees as assigned.
- Lead a team of managers and professional auditors responsible for complex and large engagements in terms of product, location or client relation
- Assess the impact of regulatory developments that could impact lines of business, and where appropriate, support the development of new control mechanisms and policies
- Assess the sufficiency of controls and policies for current regulatory requirements, and where appropriate, support the development of enhanced control mechanisms
9
Experience For Enterprise Global Regulatory Compliance Delivery Manager Resume
- Ensure compliance with all applicable lending laws and regulations; coordinate and ensure implementation of responses to exam/review comments
- Draft bulletins and communications to outline updates and action plans
- Proactively monitors regulatory activities in assigned markets; works internally (including with cross-segment Mars partners) and externally to address and influence proposed regulations to preserve Wrigley’s freedom to operate
- Experience in scientific and/or regulatory compliance with food products and related product categories (such as food supplements, cosmetics, pharmaceuticals and natural health products) with proficiency in food law, nutrition policy, and nutrition and health claim regulations for North America
- Experience working on large-scale compliance projects involving formulas, ingredients, and labelling; a demonstrated track record of working successfully across functions to achieve shared goals; and proven ability to interact cross-functionally at all levels within the organization are required
- Oversees continuous monitoring, reporting processes and responds to various inquiries and requests for information from various federal and individual states' regulators
10
Experience For Manager, IT Regulatory Compliance Resume
- Work with legal to monitor and provide interpretation and clarification of changing regulations; analyze business impact and recommend appropriate business and procedural changes
- Maintain inventory of current significant laws and regulations affecting JDF operations
- Manage the implementation of new regulations and requirements
- Report on compliance, regulatory issues and areas of concern through the Audit Committee of John Deere Financial, f.s.b. and the Regulatory & Compliance Committee
- Assesses and anticipates resource needs including skills and training requirements
- Develop and maintain various policies, program and reporting activities
List of Typical Skills For a Manager, Regulatory Compliance Resume
1
Skills For Manager Regulatory Compliance Resume
- Serve as liaison for HIFC to foster good working relationships with internal audit and regulatory agencies affecting HIFC
- Experience interpreting regulations and translating regulatory requirements into practical strategies. is required
- Extensive experience in managing regulatory compliance and/or legal practice including in-house corporate position
- Very detailed understanding and working experience with SAP
- Assist Senior Management in maintaining effective interactions with FCAC and other regulatory bodies, as appropriate
- Experience with FPRP and billing rates
- Current or previous Previous Import Experience required supporting US / Americas
2
Skills For Senior Manager OTC Consumer Regulatory Compliance Resume
- Previous Federal Consulting and/or professional services experience
- Experience working with trade associations and government agencies to clarify and resolve regulatory matters is required
- Establish effective working relationships and build creditability within the organization to support a culture of compliance based on the Company's core values
- OTC derivative collateral management experience
- Experience with Wealth businesses and securities regulations
- Strong attention to detail with ability to see the "bigger picture"
3
Skills For Regulatory Planning & Compliance Manager Resume
- Background with in trusts, registered plans and pensions, tax and securities industry experience in Canada and/or the US
- University education or equivalent experience
- Manage site validation programs
- Experience with CAS and FAR and associated government challenges
- Experience with DCAA/CACO relationships
- Strong knowledge of cost allowability
- SAP and Excel work experience
- Being the outsourcing team’s regulation expert for all post execution trade regulations
- Ensuring all lifecycle management processes are compliant with all applicable regulation e.g.including MIFID II and EMIR etc.
4
Skills For Manager, Regulatory Compliance Management Resume
- Working with local markets and Regional teams, coordinate the review of draft CCDS and feedback of comments to global CCDS team within the agreed timelines
- Responsible for hiring, retention, coaching, motivating, and providing performance appraisals of staff
- Discharge the accountabilities set out in the HIFC Head Office Compliance Procedures Manual by monitoring, reporting, and fostering a compliance culture
- Work with testing teams from the control partners providing input on coverage and their ability to rely on business testing
- Develop and improve service operating models including processes, tools and techniques for the ongoing management of security services
5
Skills For Manager, Regulatory Compliance Testing Resume
- Provide mentoring and coaching of other team members; assist management in developing talent
- Knowledge of due diligence standards respecting Anti-Money Laundering and Know Your Client requirements an asset (Wolfsberg)
- A sound understanding of the regulatory framework affecting financial services entities within Australia
- Participate on teams introducing new chemical products and make modification to existing product lines
- Advise senior management regarding compliance initiatives, develop plans for ensuring compliance and provide management system guidance
6
Skills For Manager, Regulatory & Compliance Resume
- Responsible for the global adverse event reporting program, including communications to regulatory authorities
- Assists in establishing operating procedures to ensure compliance with applicable legal and regulatory requirements
- Quickly acquire local knowledge and shift between local and regional situations+ learning agility
- Responsible for maintaining the inventory of policies and procedures mapped to regulations, to key operational risk processes, and to controls
- Support reporting on the overall status of the businesses RCM program
- Oversee the management of reviews of the businesses control environment by control partners including external auditors, Internal Audit, Compliance, and GAML
- Responsibility for the integrity of regulation based processes and the daily regulatory reporting for all the teams’ clients
- Knowledge of the requirements for documenting items in international jurisdictions where Company’s products are currently sold (i.e.)
- Certified Anti-money Laundering Specialist (CAMS). In-depth knowledge of AML/ATF regulations
7
Skills For Regulatory Compliance Risk Manager Resume
- Federal Banking Agencies (FBA) / Federal Financial Institutions Examination Council(FFIEC) supervisory / examination process
- Bank Secrecy Act (BSA), Anti-Money Laundering (AML) and Office of Foreign Asset Control (OFAC) compliance requirements
- Knowledge of the rulemaking process and be able to provide input to the process in the Company’s best interest
- Manage international employees’ compliance with current corporate training requirements
- Play a significant role in managing the Federal Reserve relationship
- Support accreditation initiatives, including, NCQA and HEDIS
8
Skills For Regulatory Compliance & Environmental Manager Resume
- Accountable for ensuring recall processes adhere to global regulations and internal procedures
- Responsible for managing compliance communications with regulatory agencies worldwide
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance
- Creates, compiles and distributes reports regarding compliance and quality metrics
- Responsible for obtaining third party products classification, valuation, country of origin, and other government agency requirements
9
Skills For Enterprise Global Regulatory Compliance Delivery Manager Resume
- Verification and record keeping of US export / US re-export license program for Corp and ALL subsidiaries (10%)
- Enthusiastic team member with a proactive approach to assignments
- Able to travel ≥ 25% per calendar year
- Detail-orientation combined with big picture orientation
- Where necessary, work with regional Medical Affairs team to support local markets with comparative reviews of a local SPC against a newly issued/updated CCDS
- Provide support to the local markets or market clusters in the preparation of variation packages once the final CCDS is issued for EMEA
- Liaise with global and regional subject matter experts (SME), and assist local markets and market clusters in preparing responses to RFIs following safety submissions to relevant Health Authorities
- Identify opportunities for market collaboration and preparation of common supporting documentation for simultaneous safety variation submissions, thus avoiding duplication of effort
- Support the Regional Regulatory Affairs (RA) team tin the successful coordination of MRP/DCP CCDS/safety submissions
10
Skills For Manager, IT Regulatory Compliance Resume
- Manage the Canadian P&C regulatory compliance and attestation process, including developing and maintaining an in-depth understanding of the regulatory requirements applicable to Canadian P&C, interpreting those requirements, understanding implications and exposures for Canadian P&C Product Suite
- Maintain detailed knowledge of all legislative requirements applicable to Canadian P&C and all risk and compliance related Corporate Standards, Corporate Policies and Operating Directives
- Providing subject matter expertise and coordination support to Canadian P&C’s participation in Enterprise level risk and compliance framework programs (i.e. Quarterly Regulatory Compliance Attestations, Operational Risk Loss Event reporting, etc.)
- Provide primary analysis of proposed rulemakings that are likely to have a significant impact on the company’s business units and develop recommendations for appropriate compliance strategies
- Audit the company’s hazard management and loss prevention programs through continual review of policies, procedures, rules and guidelines; determine potential for environmental liability issues
- Maintain the company’s Process Safety Management and Risk Management Programs. Ensure all regulatory requirements have been satisfied and necessary actions have been taken at all applicable facilities to maintain compliance
- Attending various industry events
- Representing the team at various internal functions or on different internal committees
List of Typical Responsibilities For a Manager, Regulatory Compliance Resume
1
Responsibilities For Manager Regulatory Compliance Resume
- Reviews remediation action plans for acceptability and leads and executes audit follow-up activities to verify effectiveness of audit corrective action plans
- Responsible the annual risk assessment, vendor validation and C-TPAT annual submissions
- Prioritize, organize, and accomplish work and possess a positive attitude
- Skilled problem solver with superior leadership qualities
- Proficient in the ACE reporting and functionality. Provide training as appropriate
- Coaches others on regulatory risk and return management techniques and provides necessary training
- Have functional understanding of the company’s risk profile and the impact of product decisions on the company’s core financial performance
2
Responsibilities For Senior Manager OTC Consumer Regulatory Compliance Resume
- Provide direct supervision or work direction to department personnel and regulatory auditors
- Develop, manage and conduct related training for employees; provide career development advice to employees to ensure their ongoing job satisfaction and professional development
- Defines Allstate Financial’s (AF) Regulatory Compliance Risk and Return Management objectives and assists in the development of the risk management strategy
- Directs and is responsible for work of regulatory compliance risk and return team
- Executes performance management and development plans for all direct reports
3
Responsibilities For Regulatory Planning & Compliance Manager Resume
- Fosters an environment of high performance, accountability, customer focus, leadership, and integrity
- Lead the coordination on the review of draft CCDS’s (working with local markets and Regional teams) with regional RA franchise for LOC RA comments back to global CCDS teams ensuring timely completion
- Where necessary, support local markets with comparative reviews of a local labeling (PI, PIL, primary pack/carton labels) against a newly issued/updated CCDS
- Coordinates & assists with franchise RA in the preparation of variation packages after thefinal CCDS is issued for APAC
- Assist local markets and cluster of markets with regional RA franchise in the process and preparation of responses to RFIs following submissions to relevant Health Authorities
- Work closely with business, security and IT teams to define, document, communicate, and deliver on eGRC program commitments and operational initiatives
- Oversee the development of a variety of eGRC and security deliverables, including: security and risk assessment reports, network, and data flow diagrams, privacy impact assessments (PIA), contingency plans, milestones, etc
- Communicate project status, issues and risks in a timely manner to stakeholders
- Owns, manages, and executes Compliance Follow-Up Programs, including authoring procedures, developing schedules and resourcing, conducting independent remediation verification activities, documenting results, reporting on follow-up status, escalating any identified risk, and continuously improving program effectiveness
4
Responsibilities For Manager, Regulatory Compliance Management Resume
- Works with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides compliance subject matter expertise to ensure the development of robust corrective action plans that address the root cause of issues
- Partners with IT Q&C and Q-CSV CoE to execute gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidances, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps
- Owns and continuously improves ITS and Q-CSV CoE compliance programs associated with remediation follow-up activities for new regulation gap closure; health authority observation commitments; internal audits; supplier audits; and computerized system periodic reviews
- Responsible for coordinating those systems necessary for planning, implementing, monitoring and evaluating the hospital’s continued compliance with regulatory standards outlined by federal, state and local statutes
- Provide support to the RC Executives on various projects and initiates aimed at making sure that there is sufficient awareness around RC projects/initiatives to the RC Function as well as Enterprise Wide audience in HSBC Canada as it applies
- Discharge the accountabilities set out in the Compliance Officer Handbook by proactively assisting management in identifying and containing compliance risk, monitoring, reporting and certification, fostering a compliance culture and optimizing relations with regulators. Ensure adherence to the Compliance FIM
- Maintain awareness of major regulatory changes affecting HSBC Canada and work with all stakeholders to ensure that products, services, operations and procedures remain compliant with applicable RC policies
- Strong and effective communicator; be able to dialog with all supply chain, manufacturing entities, Brokers, carriers and Regulatory Agencies
5
Responsibilities For Manager, Regulatory Compliance Testing Resume
- Conduct periodic training (foreign and domestic) and answer day-to-day regulatory trade compliance questions
- Ensure appropriate liaison and coordination with other Regulatory Compliance (RC) compliance staff in the delivery of RC guidance
- Proactively assist the COO, Compliance, Local Compliance Officers and line management in identifying and mitigating regulatory compliance and reputational risk and to help foster a compliance culture
- Coordinates specifically with international distributors to ensure that they have the necessary documentation to properly register the product in the distributors’ jurisdiction with necessary government agencies such as the Ministry of Health in the country or countries the distributor sells to
- Develop, maintain, and monitor regulatory/compliance SOP’s
6
Responsibilities For Manager, Regulatory & Compliance Resume
- Review business practices, draft or improve Trade Compliance Procedures, and develop instructional material
- Respond to inquiries from state and federal regulators
- Contribute regulatory compliance leadership to multi-disciplinary teams, in support of Enbridge’s response to regulator-involved incidents, inspections, investigations and audits
- Monitor and continually improve Enbridge regulatory reporting processes to ensure accurate and timely submissions to regulatory bodies
- Liaise with other internal regulatory and legal professionals and internal stakeholders to ensure consistency in compliance approaches across the Enbridge enterprise
- Lead through influence and mentor less experienced team members
- Provide training and guidance as required to key internal stakeholders
- Support or lead communications with Regulators
7
Responsibilities For Regulatory Compliance Risk Manager Resume
- Working knowledge of Canadian regulations/standards, in particular those pertinent to the National Energy Board and provincial energy and safety regulators in Alberta and British Columbia
- Demonstrated Management System experience
- Comprehend and provide guidance on a diverse range of regulatory, operational and complex technical issues
- Strong aptitude for technical and formal writing, including position papers, process and procedure documents, functional templates, correspondence to regulators
- Communicate orally and in writing to a wide variety of people, including employees, all levels of management and regulators, for technical and non-technical audiences
- Ensure Integrated Care staff and leadership training on regulatory and government contracts requirements are being met
8
Responsibilities For Regulatory Compliance & Environmental Manager Resume
- Display composure and courtesy when acting as an Enbridge representative
- Strong attention to detail, particularly as it relates to understanding regulations, technical standard documentation and internal process/procedure documentation
- Proficient computer skills, particularly with the Microsoft Office suite, SharePoint, and other database and collaboration tools
- Provide support to the Integrated Care organization in assessing, interpreting, and incorporating new and revised regulatory and government contract requirements
- Remain current in federal/state laws and regulations, industry standards and best practices as they pertain to Integrated Care
- Report key statistics and trends of Integrated Care compliance functions to Leadership and Company Leadership for risk mitigation and improvement opportunities
- Track and trend issues to identify performance improvement opportunities; provide input for executive regulatory report card
9
Responsibilities For Enterprise Global Regulatory Compliance Delivery Manager Resume
- Oversee the Integrated Care department program to address regulatory and legislative inquiries (complaints)
- Serve on designated external and internal committees to represent regulatory and contractual requirements
- Participate in RFP process, development and coordination of federal and state contract requirements
- Verify that all regulatory policies and procedures have been documented, implemented, and communicated
- Direct the development or implementation of compliance-related policies and procedures throughout an organization
- Provide management and oversight of professional staff
- Leads Clinical Trials Quality Assurance Team responsible for the oversight of clinical studies
- Acts as a liaison to the FDA and other regulatory agencies; be able to effectively communicate issues and responses to the FDA as well as communicate directives from regulatory agencies to the company’s management team
10
Responsibilities For Manager, IT Regulatory Compliance Resume
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed
- Serves as key point person for Pharma partner audits. Represents Clinical Quality Assurance for external audits
- Works with the local and global quality teams as needed
- Reviews new product constructs and provides compliance and consumer protection related guidance supporting internal clients on matters pertaining to insurance and service contract requirement, as well as compliance obligations and processes of the Company
- Management of the regulatory compliance processes at satellite offices and home site
- Monitors activities of the distribution centers to optimize compliance. Performs periodic on-site reviews of the distribution centers activities related to the handling of international movement of products
- Develops employees both technically and in terms of leadership skills (35%)
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