Regulatory Consultant Resume Sample
Jovanny Stark
780 Flavie Park,
Philadelphia,
PA
+1 (555) 180 8150
Work Experience
Senior Regulatory Consultant
10/2015
-
PRESENT
San Francisco, CA
- Ensure ownership for implementation
- Serve as the FFM Exchange lead by overseeing end to end administrative operations and responding to questions and issues from the regulator
- Monitor all product and rate filings
- Lead the QHP recertification Community of Practice and oversee successful QHP recertification in all jurisdictions
- Responsible for project oversight relative to implementation of new Federal Commercial and Medicaid regulations, rules or laws
- An understanding of business operations and business functions and how regulations impact business operations
- Fosters comprehensive regulatory management through a series of activities to comply with all applicable regulations and statutes. Activities include
- Implementing: identifying regulatory requirements and conducting related analyses; creating or revising regulatory standards, policies, and procedures; monitoring regulatory adherence; and reporting on regulatory efforts and programs, and validating: reviewing regulatory programs and content,
- Researches and stays abreast of regulations and statutes. Determines impacts of implementation of new regulations and statutes and required notifications, changes, and training. Communicates required changes, and leverages existing workgroups/etc. to facilitate required changes. Lead the development of operational policies and procedures
Regulatory Consultant
05/2009
-
07/2015
Chicago, IL
- Proficiency with spreadsheets is required
- Conducts research and supplies information as requested through the assistance of more senior team members
- The broad regulatory agenda (Solvency II, Basel III and the new SSM world, MIFID & the Consumer Protection agenda, …), and its operational impact
- The qualitative aspects of risk management (ERM, governance, policies, reporting)
- Internal audit and processes & control
- Quantitative modeling (market risk, valuation, credit risk), including the link with accounting (e.g. IFRS 9)
- Participates in the development of input necessary for presentation of rate filings and other reports to regulatory agencies and customers. Respond to discovery requests and Commission audits
- Develop an understanding of the fundamentals of state or federal regulation standards, codes, concepts, systems, and business processes relevant to work assignments
Mutual Fund Operations Regulatory Consultant
07/2006
-
11/2008
Philadelphia, PA
- Solve straight-forward problems or, with support, guidance, and direction, perform analysis to accomplish work plans initiated by various governmental agencies for rate cases, recovery clauses, audits, compliance filings, policy matters, and/or other proceedings
- With support, guidance, and direction, complete requested tasks to gather information to contribute to regulatory strategy development and coordination, and
- Contribute information for others to develop negotiation strategies
- Through training and directed task execution, acquire knowledge of developments, procedures and current events affecting regulatory activity, and
- Perform routine assigned tasks to support the implementation of necessary changes
- Conduct research and provide critical regulatory evaluation of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans
- Supervise the preparation of administrative and technical components of regulatory agency submissions for the conduct of clinical trials, for product registration, and for post-approval maintenance, in electronic common technical document (eCTD) format
Education
John Paul the Great Catholic University
2000 - 2005
Bachelor's Degree in Business
Professional Skills
- Strong writing skills; ability to periodically prepare written responses to regulators
- Demonstrated experience overseeing and performing regulatory compliance reviews or providing other compliance management consulting services
- Proficient oral and written communication skills, including the ability to articulate strategy and provide guidance to management and witnesses on case
- Demonstrated ability to handle multiple projects simultaneously and prioritize projects
- Uses critical thinking and analytical skills to analyze issues
- Very skilled in analysis and detail oriented; able to identify and assist in solving problems effectively
- Intermediate facilitation, training, and presentation skills
How to write Regulatory Consultant Resume
Regulatory Consultant role is responsible for interpersonal, research, intermediate, presentation, analytical, strategy, articulate, modeling, reporting, consulting.
To write great resume for regulatory consultant job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Consultant Resume
The section contact information is important in your regulatory consultant 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 Regulatory Consultant Resume
The section work experience is an essential part of your regulatory consultant 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 regulatory consultant responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory consultant position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Consultant resume experience can include:
- Experience designing and executing on effective project governance models for large enterprises
- Strong knowledge/experience conducting quality audits
- Utilize project management skills to ensure completion of key processes
- Prepare and support written testimony to effectively communicate the Company’s advocacy in various regulatory proceedings
- Experience building compliance management systems, including performing Compliance Risk Assessments
- Experience in performing Fair Lending and CRA risk assessments and Fair Lending reviews/audits
Education on a Regulatory Consultant Resume
Make sure to make education a priority on your regulatory consultant resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory consultant 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 Regulatory Consultant Resume
When listing skills on your regulatory consultant 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 regulatory consultant skills:
- Excellent written and verbal communication, critical thinking and analytical skills
- Strong interpersonal skills; ability to interact with a broad variety of people at many levels inside and out of the firm
- Strong analytical skills; ability to use internal systems to collect information for regulators
- Proven ability to communicate effectively and efficiently both oral and written
- Strong legal research skills (i.e. Lexis/Nexis, NILS, Westlaw, etc.)
- Excellent communication skills – written, verbal and formal presentation
List of Typical Experience For a Regulatory Consultant Resume
1
Experience For Senior Regulatory Consultant Resume
- Strong presentation skills; intermediate level of proficiency with word, excel, power point
- Experience with working within a health care or government environment with experience in compliance / regulatory
- Experience completing compliance monitoring, testing and/or compliance internal audits
- Experience in designing or evaluating compliance management systems for financial institutions
- Build strong working relationships with your stakeholders and business SME’s
2
Experience For Banking Risk & Regulatory Compliance Business Consultant Resume
- Some experience in domains of Customs/Tax/Export compliance/Audit
- Good knowledge of the CAT parts business model and Grimbergen DC set up
- Define and deliver effective solutions to business and regulatory risk issues and within agreed timescales
- Accepts and responds to priority issues received from call agents and/or customer requests for escalations
- Demonstrated ability to manage multiple projects with accuracy and precision
- Experience evaluating adverse events
3
Experience For Mutual Fund Operations Regulatory Consultant Resume
- Experience in identifying compliance risks and broad knowledge of risk mitigating controls
- Good understanding of performing the above tasks on a global level
- Experienced in implementing small to intermediate business or technology projects
- Regulatory compliance, data analysis, or business assessment experience
- Working with the Health Plans / delegates on CAPs and monitoring for any identified deficiencies
- Working with Operations to ensure accurate implementation
- Working with Business Intelligence and HCE business partners
4
Experience For Regulatory Adherence Consultant Resume
- Assists management in preparing and reviewing records and reports pertaining to the operations of the License Operations Unit
- Assists management in preparing and reviewing records and reports pertaining to the operations of the Operation Support Unit
- The role of the various actors in the planning, selection and negotiation process leading to the signing of the PPAs
- Work on a team supporting complex licensing projects to support Operational growth initiatives, as assigned
- Provides exemplary customer service to both internal and external customers when giving directions on application processing requirements
- Extensive knowledge of the department's document imaging and licensing system
5
Experience For Principal Consultant Regulatory Resume
- Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
- Submission Publishing and/or Viewing systems
- CJIS (Criminal Justice Informational Services) Training and Test within 6 months of hiring date, biannual thereafter
- Artwork updates (mainly collaborating with client artwork teams & their manufacturing plants to timely update mock-ups i.e. carton, leaflets etc.)
- Build repositories and reporting to document compliance with regulatory requirements while also making sense for the business
- Design and prepare briefing packages for regulatory agency meetings or advice and lead these agency interactions
- Lead the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, budgets, and strategies
6
Experience For Regulatory Oversight Consultant Resume
- Meet independently with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities
- Design training materials and share best practices in the regulatory area, both internally and externally
- Can do attitude – willing to broaden knowledge in compliance and regulatory areas
- Assist in developing new and revised business processes in response to Group, Market and regulatory requirements within agreed timescales
- Participate in planning, coordination, and fulfillment of client engagements
7
Experience For Finance & Risk-regulatory & Compliance Consultant Resume
- Assist and support in the generation of proposal for prospective and existing clients
- Knowledge of application requirements, including Florida Statutes, Board and Department rules, and educational programs
- Primary customer liaison managing communication between project team, customer and internal stakeholders
- Registration Data Tracking Systems
- Audit/assess multi-year Design History File (including product and software)
8
Experience For Regulatory Compliance Senior Consultant Resume
- Proficient with Microsoft Office, including: Word, Excel and Powerpoint
- Participate in a team environment in the marketing of company services and business development
- Perform routine research and follow-up and creating executive reports/analyses
- Aid in problem solving tasks in area of specialization
- Prepare reports relating to examination development
- Knowledge of application requirements, including Florida Statutes, Division and Department rules, and educational programs
- Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC
9
Experience For Senior Consultant, Regulatory Affairs Resume
- In pharmaceutical industry/CRO with focus on regulatory affairs for marketing authorization and /or clinical research
- In pharmaceutical industry/CRO with focus on regulatory affairs for Marketing Authorization and /or Clinical Research
- Work with a multinational team, focusing on multiple issues under tight timelines
- HA responses related to labelling submission (ideally to US FDA & EU HAs)
- Updates to the labelling sections of US FDA Annual Reports
- Able to distill large volume of information into a compelling and concise business “story”
- Represent regulatory in internal or external project audits
- Represent regulatory on internal cross-functional initiatives
- Support projects and process work by establishing measurable goals, objectives and requirements relative to a specific area of responsibility; addresses company system-wide issues within specialized field of expertise; and reviews planned work of others
10
Experience For Pension / Regulatory Consultant Senior Resume
- Keep abreast of changes to regulatory legislation impacting compensation practices in EMEA, developing/maintaining strong external relationships with relevant consultant, industry groups, and peer networks
- With oversight and input from the EMEA Regional Compensation Lead
- With oversight and input from the Regional Head of Compensation EMEA
- Assist in the delivery of projects in the above described business area’s
- Highly customer focused – frequent contact with CAT dealers
- Knowledge of SPM/CRM is an asset
List of Typical Skills For a Regulatory Consultant Resume
1
Skills For Senior Regulatory Consultant Resume
- Strong research, analysis, problem-solving, decision-making and relationship management skills
- Competent influencing and negotiation skills; able to influence and advise compliance peers in a de-centralized organization
- Highly proficient Excel VBA skills
- Legal, Compliance, Risk, Audit experience and/or relevant line of business experience in institutional or retail wealth and investment management
- Communicate effectively and efficiently both oral and written
- Intermediate interpersonal and advocacy skills
2
Skills For Banking Risk & Regulatory Compliance Business Consultant Resume
- Experience in hydro power-related licensing or similar experience is required
- High level of interpersonal skills and integrity
- Proven ability to manage multiple projects and priorities independently
- Prior experience with Compensation, Compliance, Risk or Audit
- Communicate effectively and efficiently both verbal and written
- Basic grammar skills
- Experience in analyzing Fair Lending and CRA data
- Experience with researching and evaluating complaints in any type of customer service or quality function (dietary supplements and OTC drugs ideal)
- Experience with handling complaints in any type of customer service or quality function, performing research and investigations
3
Skills For Mutual Fund Operations Regulatory Consultant Resume
- Influential; experience leading teams through hard decisions and negotiating compromises
- Experience in managing regulatory change projects in a financial institution
- Experience in interpreting regulatory changes and development of solutions to address those changes
- Experience in networking and new business development opportunities and partnerships
- Experience performing regulatory review of product complaints
- Experience working with regulators such as CMS, State Medicaid, Boards of Pharmacies, DEA, HHA agencies
4
Skills For Regulatory Adherence Consultant Resume
- Experience working with CMS requirements
- Experience working with Medicaid legislation and requirements
- Experience leading multi-year, multi-million-dollar enterprise sized implementations
- Experience in an IVD or medical device manufacturing environment
- Master / Ph.D. in life sciences or related science/engineering background with a strong emphasis in biologics
- Experience in financial services with 5 years specific to Mutual Funds
- Demonstrates the highest levels of ethics and integrity
- More than 10 years experences on Qualtiy Assurance with GMP inspection experiences
- Direct support experience with OptumRx pharmacies, BriovaRx Specialty pharmacies and/or BriovaRx Infusion Services pharmacies
5
Skills For Principal Consultant Regulatory Resume
- Experience with financial modeling (analytic modeling and net present value analysis)
- Work independently with minimal supervision, manage multiple, competing priorities and meet strict deadlines
- Experience of working in a regulated environment with a focus on customer outcomes
- Performs internal quality audits and prepares files and evidence for regulatory audits; designs training documents for audits and implementation roll out
- Strong knowledge of the U.S. banking laws and regulations
- Experience in working with or for financial services companies
6
Skills For Regulatory Oversight Consultant Resume
- Experience in working in complex and dynamic environments
- Experience working in a Government, Healthcare, Managed Care or Health Insurance environment
- Experience working in a Dental Insurance environment
- Experience with Regulatory Filings and working with Regulators
- Experience and knowledge working with State Level Regulators and Regulatory Agencies
7
Skills For Finance & Risk-regulatory & Compliance Consultant Resume
- Experience working in an utility and/or energy company
- Experience with managing energy efficiency programs
- Strong knowledge of, and ability to apply consumer financial laws and regulations
- Experience with TPRM (Third party risk management), Cyber regulations, Privacy regulations and Crypto regulation highly desirable
- Handle confidential and proprietary information with discretion, and balance risk and reward with a strong focus on compliance
- Demonstrated ability to contribute independently and supervise, direct and develop staff
- Expert on life sciences compliance and computer systems validation requirements
- System implementation experience either as a consultant, business or IT representative for at least one of the following systems
- Strong knowledge of 21 CFR Part 820.30 Design Controls
8
Skills For Regulatory Compliance Senior Consultant Resume
- Regulatory systems and process experience
- ECTD and CTD documentation experience
- Preparing, reviewing and compiling regulatory Clinical Trial Approval applications, amendments, and end of trial notifications
- Meeting requests and meeting packages for pre-IND and/or Scientific Advice meetings,
- Authoring Module 3 and defining regulatory strategy - work with cross functional team to author documentation and define strategy
- Understanding of Commercial, Medicare, and Medi-cal
- Providing regulatory knowledge and adherence to the approvals processes in relation to Financial Promotions and other related projects
- Undertaking activities for the team as delegated by the Team Leader
9
Skills For Senior Consultant, Regulatory Affairs Resume
- Assisting in assessment and advising on the impact of regulatory change and actions to address impact
- Assisting in the development of compliant solutions through working with the business
- Building relationships with and influencing a wide range of stakeholders
- Understanding of Bank of America business and structure
- Optimising internal processes and controls
- Program and project management including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
- Perform project management tasks including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
- Provides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agencies
10
Skills For Pension / Regulatory Consultant Senior Resume
- Proactively discussing and preparing relevant material for Marketing Propositions for approval by the Regulatory Approvals Team Leader (where required)
- Knowledge of the CCC and Department's systems including the licensing database and document imaging system
- Knowledge of Florida Statutes and board and department rules governing licensing and regulation
- Extensive knowledge of the department's document imaging and licensing systems
- Provider data maintenance, contracting, or contract loading
- Adept using databases and creating basic reports in Excel
- Provides guidance and support to call center agents when researching and responding to more complex questions received in the call center
- Knowledge of the techniques for handling complaints and dealing with the public
List of Typical Responsibilities For a Regulatory Consultant Resume
1
Responsibilities For Senior Regulatory Consultant Resume
- Proven ability to conduct basic internet search and navigation
- Experience using Excel VBA to implement and automate processes involving large quantities of data
- Evaluate adverse events; using internet research and creative/strategic assessment
- Use existing software (Astute) to run case reports
- Active Participation in team meetings and brainstorming sessions
- Assists the Regulatory Program Administrator with all aspects of the unit to include training call agents on subject matter, software, and computer systems
- Provides feedback to management regarding trends and conditions
- Develops and/or modifies requirements, business design specifications, user training and documentation
2
Responsibilities For Banking Risk & Regulatory Compliance Business Consultant Resume
- Tests and documents solutions while serving as the liaison between users of the tool and technical staff/vendor
- Performs user acceptance testing as new systems are implemented
- Develop and maintain relationships between AEP’s Central Regulatory business unit and its regulated operating companies
- Support the ongoing relationships between AEP’s OPCOs and various regulators and interest groups involved in the regulatory process
- Location is Grimbergen DC, limited travel requirements
- Participate in regulatory associations and industry conferences to keep informed of regulatory and industry changes, exchange ideas, and represent and advance the organization’s positions
- Coordinate and prepare the organization’s comments to government agencies regarding proposed regulations
- Quickly learn new software programs, run reports and analyze simple data is key
3
Responsibilities For Mutual Fund Operations Regulatory Consultant Resume
- Understand client’s general business and technology environment, and work with team members to recommend and implement solutions
- Serve as CCT’s lead Regulatory person
- Approval and sign off in respect of Financial Promotions and related projects
- Provide regulatory knowledge and support when working with the wider team and the business, to review, influence and develop appropriate regulatory strategies and practices in an ever changing marketplace
- Ensuring consistency in the application of regulation across Personal in the approach to financial promotion approvals, adhering to set processes and advice given by Line 2 Regulatory Compliance Team
- Use regulatory knowledge and information to effectively work with the business to monitor, influence, maintain and improve regulatory standards
- Proactively liaise with other relevant functions to consider opportunities to deliver best practice which are relevant to regulatory approvals
- Effectively maintain your regulatory knowledge, ensuring the application of this is in line with any advice or learnings provided by Line 2 Regulatory Compliance
- To ensure that any guidance, discussions and/or advice given is recorded and shared with the team
4
Responsibilities For Regulatory Adherence Consultant Resume
- Provide financial and technical analyses for energy conservation, resource planning and rates-related regulatory filings, particularly as they relate to CIP/DSM programs
- Develop and operate complex business and financial models to assess cost effectiveness and strategic value of demand-side management and demand response programs
- Manage cross-functional project teams for Business Unit strategic initiatives
- Maintain constructive relationships with external (regulators and other stakeholders) and internal customers. Develop arguments and analytical support for regulatory filings for CIP/DSM programs
- Complete Special Projects related to regulatory issues as required
- Communicate regulatory issues across Business Unit
- Provide support and guidance to the Operational areas
5
Responsibilities For Principal Consultant Regulatory Resume
- Assist in audits and new business implementations
- Process consumer returns related to complaint reports
- Collaborate with other departments to ensure completion of cases
- Perform Regulatory review of product complaints
- Coordinate updates with Regulatory and Quality
- Download reports from adverse event database and manage changes/updates
- Create and present quarterly presentations to Brand teams
6
Responsibilities For Regulatory Oversight Consultant Resume
- Communicate with outside vendors and prepare new product files to be sent out
- Work with medical consultant to complete Medwatch for submission to FDA
- Compile data and create product dossiers
- Serves as a subject matter expert and has comprehensive knowledge of each of the professions and businesses supported in the call center
- In the absence of the Supervisor, oversees the day to day operations of the team and the tasks associated with employee performance
- Assists management in analyzing processes including interpretation of laws, rules, policies and standards and recommends changes to improve operations, to save time, labor and other costs to improve quality control and operation efficiency
7
Responsibilities For Finance & Risk-regulatory & Compliance Consultant Resume
- Responds to telephonic and email inquiries regarding all DBPR licensing matters or requirements, continuing education requirements and fees. Utilizing the Department’s system to research and locate information. On behalf of the Department, accepts licensing fees from customers. Accepts requests for public records
- Communicate effectively verbally & in writing, ability to train individuals, ability to investigate, analyze and route DHR related complaints as needed
- Self-monitoring – assist with identifying operational risk and mitigating risk
- Understand and explain statutes, rules and regulations
- Understand and apply applicable rules, policies and procedures regarding licensure and regulation of professionals, and ensure consumer protection as it relates to the professions we regulate
8
Responsibilities For Regulatory Compliance Senior Consultant Resume
- Understand client's general business and technology environment, and work with team members to recommend and implement solutions
- Manage an assigned portfolio of licenses - specifically in the Pharmacy and Government Programs space (Medicare/Medicaid)
- Actively participate in the development, implementation, and maintenance of the operational compliance program within Claims in order to ensure that we are meeting company guidelines and regulatory (e.g. CMS, state) requirements
- Establish, document, and implement standard policies, procedures, processes and best practices across the business to promote compliance with applicable laws and contractual obligations
- Experience with interacting with external customers, communicate Optum's position related to regulations and the demonstrated ability to negotiate the changes that impact the customer
- Equate Federal and State requirements to operational processes through demonstrated technical knowledge of various claim platforms and administrative tools
- Identify weaknesses and gaps, improve processes, analyze data, and communicate observations, findings and recommendations
- Assists the Regulatory Program Administrator with all aspects of effective and efficient operation of the unit, to include training, assisting bureau staff, and testing of process changes to the License Operations Unit
9
Responsibilities For Senior Consultant, Regulatory Affairs Resume
- Assists management in analyzing processes including interpretation of laws, rules, policies and standards and recommends changes to improve operations, to save time, labor and other costs to improve quality control and operating efficiency
- Researches and processes cancellation and withdrawal requests utilizing the department's document imaging and licensing system
- Utilizes Microsoft applications to maintain reports for tracking cancellation and withdrawal requests
- Performs quality checks on applications prepared for board and committee meetings and maintains the respective lists by utilizing Microsoft applications
- Provide relevant training to customers about new regulatory trends and developments
- Safeguard Merck Life Science strategic interests and objectives in arising guidance, standards and regulation
- Help drive process improvements based on a thorough understanding of the processes and the implications to the LOBs
10
Responsibilities For Pension / Regulatory Consultant Senior Resume
- Represents management in the Bureau of Central Intake and Licensure in matters as authorized and assigned. Reports events, errors or trends to supervisor
- Basic Internet research and navigation
- Architect multi-year and multi-phased implementation programs to deploy Vault RIM across an organization globally
- Mentor project team and junior consultants in the R&D Services organization
- In depth knowledge of drug development processes and regulatory submissions
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