Regulatory Program Manager Resume Sample
Freeman Ritchie
6401 Salma Forks,
Chicago,
IL
+1 (555) 232 3465
Work Experience
Regulatory Program Manager
04/2016
-
PRESENT
Phoenix, AZ
- Managing all aspects of a project, including project planning, execution, timing, quality, cost and early identification of potential risk and issues
- Providing the program manager and stakeholders with transparent, accurate and regular information regarding the program status
- Working as part of a matrix organization, ensuring efficient use of resources with a hands on approach where required
- Identifying and managing key stakeholders and clients, evaluating their interests and establishing effective communication, highlighting assumptions and dependencies
- Embedding risk awareness by designing and operating an effective control environment, proactively identifying and raising control deficiencies and driving diligent and sustainable risk remediation
- Understanding the regulatory nature of change programs and relating this to legal and compliance for guidance
- Managing a cross-functional team and all aspects of preparing a Premarket Tobacco Product Application/Modified Risk Tobacco Product Application (PMTA/MRTPA) submission that meets FDA requirements and adheres to project timeline and budget
- Working with science counterparts to develop the program of studies needed to support the PMTA/MRTPA
- Analyzing FDA information (guidance, publicly available information, decisions on competitive products, and emerging science) to determine implications to product regulatory strategies
Product Safety & Regulatory Program Manager
04/2009
-
11/2015
Phoenix, AZ
- Developing and managing related tracking, reporting and project management tools needed to successfully execute the FDA submission
- Managing interactions with company leadership to ensure appropriate evaluation of product regulatory decisions
- Communicating with internal teams to ensure smooth project execution
- Good technical knowledge of Data Management products in areas ETL, Data Quality, Meta Data Management and Big Data
- Exercises overall responsibility for the successful delivery of the project to plan, budget and agreed quality and governance standards
- Encourages direct and tough debate but isn't afraid to end it and move on. Is looked to for direction in a crisis. Faces adversity head on. Energised by tough challenges
- Works closely with the onshore based counterparts to create individual work stream plans and delivery roadmaps
- Owns and drives the planning framework, ensuring that plans are developed and tracked to appropriate standards, are integrated effectively across all work-streams, are unambiguous and achievable, and that dependencies are clearly understood and managed
- Owns and drives the effective governance of the project, ensuring that the Bank’s technical, risk & compliance and legal/regulatory requirements are met and that governance framework is comprehensively defined and firmly embedded across all areas of the portfolio
Global Regulatory Relations Group Central Team Operations & Program Manager
04/2003
-
12/2008
Detroit, MI
- Controls the delivery scope, ensuring that rigorous change control is exercised
- Quality Assurance and overall integrity of the Programme/Project
- Oversees the delivery of the project and service meets requirements and that acceptance and handover to business as usual are managed against agreed acceptance criteria and to a defined plan
- Ensures that all status reporting is accurate, informative and timely, and directly provides progress reports to the governance forums at agreed intervals
- Managing all aspects of projects and programs; taking a structured approach to project initiation, planning, execution, timing, quality, cost and early identification of potential risk and issues
- Providing management and stakeholders with transparent, accurate and regular information regarding the program status
- Ensuring business and IT deliverables are aligned to key design principles; and proactively engaging with the Design Authority
Education
Pepperdine University
1999 - 2003
Bachelor's Degree in Healthcare Related Field
Professional Skills
- Extensive previous professional experience of working as a Project Manager in a fast-paced, multi-project Financial Services environment with responsibility for resource management and project financials
- Experience heading cross-functional and matrix teams to develop and implement regulatory strategies; demonstrated project management skills
- Strong relationship management skills with proven ability to meet goals and timelines
- Demonstrated program or project management skills coordinating complex and large-scale projects
- Demonstrated excellence in interpersonal communication and supervisory skills
- Strong presentation skills to clearly and articulately share project progress and developments to peers and senior management
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
How to write Regulatory Program Manager Resume
Regulatory Program Manager role is responsible for regulatory, negotiation, government, microsoft, presentation, finance, training, database, equities, reporting.
To write great resume for regulatory program manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Program Manager Resume
The section contact information is important in your regulatory program manager 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 Program Manager Resume
The section work experience is an essential part of your regulatory program manager 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 program manager 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 program manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Program Manager resume experience can include:
- Take a leading role in further developing the change practice, through ongoing development of our people, the delivery framework and templates, contributing to the design authority and design artefacts
- Supports continuous improvement in global regulatory effectiveness; collaborates with CP Global Regulatory, Regulatory Science, and CORE experts to develop and improve regulatory processes and tools
- Experience prioritizing and managing projects with deadlines
- Teamwork and working effectively with a global teams
- Advanced skills in written and oral communication
- Work experience in the pharmaceutical, biotechnology or related industry as appropriate and CMC, quality, regulatory or related experience
Education on a Regulatory Program Manager Resume
Make sure to make education a priority on your regulatory program manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory program manager 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 Program Manager Resume
When listing skills on your regulatory program manager 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 program manager skills:
- Good interpersonal relationships and capability to operate effectively cross functionall
- Experience in effectively and confidentiality advising and interacting with all levels of an organization
- Experienced at operating effectively across locations
- Word processing skills, including Microsoft Word, Excel
- Proven track record of providing strong leadership to the change teams, business and technology
- Proven track record of providing strong leadership to the project teams, business and technology
List of Typical Experience For a Regulatory Program Manager Resume
1
Experience For Product Safety & Regulatory Program Manager Resume
- Recent experience of delivering regulatory change projects; in Asset Management or banking or insurance etc
- Experienced at leading cross-functional teams
- Experience in regulatory affairs or regulatory sciences
- Expert program management knowledge and experience
- Related experience with a Master’s
- Involved in developing, modifying and executing company regulatory policies that affect immediate operations
- Work with customers to agree standardized solutions, creating value add services for the client and strengthening the Utility proposition to the industry
- Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
2
Experience For Global Regulatory Program Manager Resume
- Monitor changes in the regulatory environment and make appropriate plans to ensure Product Control’s compliance
- Partner with stakeholders throughout CCB including Digital’s Control Partners - Legal, Compliance, Risk, and Controls for Legal/Regulatory Procedures, Action Plans, RCSA and other Privacy tasks for sustainability
- Provide regulatory support for assigned products, business areas and projects under the guidance and direction of your manager and CORA Program Directors
- Under the guidance of a CORA Program Director or your manager, support PRC interactions, meetings, other communications and deliverables and effectively collaborate with cross-functional internal groups and external advertising agencies
- Maintain current awareness of evolving Food and Drug Administration (FDA) opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders
- Collaborate with others on matters relating to marketing strategies, implementation and promotion objectives
- Support the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies
- Keep internal partners and stakeholders abreast on various PRC/CORA activities and status
3
Experience For Global Regulatory Relations Group Central Team Operations & Program Manager Resume
- As assigned, participate in special projects
- Provide ‘single-point of contact’ to the EHS team for understanding existing EHS regulations and regulatory activity (compliance of new technologies with applicable codes and standards)
- Review RRG reporting and external regulatory and industry news to identify key supervisory developments and trends; synthesize into global reports for the Firm’s senior executives and stakeholders
- Track action items, DIRT, and key decisions
- Review and oversee presentations to facilitate discussions with business stakeholders and senior executions
- Lead, encourage and manage the project team
- Prepare and communicate the project definition documents
- Produce as required plans and schedules for the project, individual project stages and exceptions with team managers and other key project personnel
- Assess, control and manage the risks to the project, prepare mitigation and contingency plans
4
Experience For Regulatory Labeling Program Manager Resume
- Day to day consultation and liaison with the programme team if the project is part of a programme. In these circumstances responsibility for ensuring a good scope fit between the different projects (no overlap or gap)
- Project level reporting via monthly reporting, steering control meetings and ad hoc reports
- Identification of lessons learned and production of the project closure report
- To source appropriate mentoring, support and advice on any aspects of the project where this is required of Investment Banking operations, technology and change landscape
- Engage with business and program teams to develop regulatory strategies and associated submission/approval programs in alignment with commercial objectives
- Facilitate communications between technical organization and regional registration staff to resolve product-specific registration issues
- Lead cross-portfolio projects and initiatives which support regulatory excellence
5
Experience For Program Manager, Commercial Regulatory Resume
- MBA and familiarity with the crop protection business
- Proven negotiation and issue management skills in dealing with government regulatory agency processes and scientific assessment issues related to obtaining and maintaining product approvals
- Desire and ability to work in a deadline-driven, highly interactive, global team environment
- Plan, coordinate, and track multiple projects simultaneously
- Proficient in computer applications such as Microsoft Office, ability to learn and master regulatory and other databases to obtain pertinent product registration information and reports
- Take a complex situation and create clarity and direction to allow progress to be made towards solutions/delivery
- Responsible for product registrations/approvals
- Recommend and develop strategies and create detailed written regulatory plans for
6
Experience For Program Manager Quality & Regulatory Resume
- Establish and provide technical competency and guidance to MCS and tactical alignment of MCS with MA&TC on regulatory aspects of
- As a core member, supports the Regulatory Program Team(s) in planning, budgeting, and implementation of a program of work to achieve regulatory strategy objectives
- Leads translation of regulatory strategy intoactionable plans for obtaining and maintaining product registrations
- 1: Intact & Cross-Functional Teams
- Participates in site and/or regional and/or global PDR Program Management departmental meetings
- 2: Regulatory Program Management
- Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
- Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
- Support our client engagement teams in marketing the successes and efficiencies achieved
7
Experience For Regulatory Affairs Program Manager Resume
- Passion for delivering great technology
- Participates in other special projects, as and when assigned, or otherwise requested
- Ensure that Syngenta’s program and project management methodologies (MSP, BCM) are followed, including proposed stage gate advancement approach, status reporting, issues and risk management
- Provides Regulatory Technical Competency (tactical and strategic) to the PCMS business group
- Represent FIS Utility at industry led regulatory forums
8
Experience For Program Manager of Regulatory Compliance Resume
- Ensure appropriate accountability for delivery of project workstreams
- Deliver complex, cross-regional projects or programs
- Manage high levels of uncertainty and ambiguity in a dynamic environment which is sometimes change resistant
- Fluent in English, any additional language beneficial
- Broad knowledge of the Syngenta business beneficial
- Business management skills particularly financial, legal and technology (IS) aspectsProven People Management & Development Knowledge of R&D and product safety and regulatory especially beneficial
9
Experience For Global Regulatory Reporting Controls Oversight Transaction Review Program Manager Resume
- In Programs or Projects
- Knowledge of core Equities front-to-back processes
- Current licensure/certification commensurate with education requirements. RN required
- Certified Safety Professional desired
- Exercise judgment within the guidelines of hospital and department policy, licensure practice acts, and regulations
10
Experience For Accreditation & Regulatory Program Manager Resume
- Apply regulatory standards to design and re-design of processes
- Apply principles of data management; monitors trends and analyses results
- Conducts mock surveys and coordinates plans of correction and/or teams to
- With product compliance and experience with regulated products such as medical devices, pharmaceuticals, hazardous materials, supplements, or chemicals
- Experience with creating, defining, and managing policies while partnering with global and local partners to gather requirements and ensure alignment on priorities, metrics for success, and operational
- Demonstrated experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Support the definition and communication strategies for regulatory exam management in order to meet Citi’s legal, regulatory and compliance requirements
List of Typical Skills For a Regulatory Program Manager Resume
1
Skills For Product Safety & Regulatory Program Manager Resume
- Excellent communication and presentation skills with the ability to succinctly convey information to senior management and other stakeholders
- Experienced at hiring, building and developing change teams
- Experience successfully navigating a fast-paced and continually evolving environment
- Recent experience of delivering regulatory change projects; in Asset Management, Banking or Insurance etc
- Lead meetings with lines of businesses and other key stakeholders regarding review scope and approach and facilitating observation validation
- Experience in auditing, consulting, legal, or program management environments
2
Skills For Global Regulatory Program Manager Resume
- Experience in auditing, consulting, legal, or program management environments
- Extensive experience in registration of plant protection products and working familiarity with regulatory testing guidelines and requirements
- Three years of experience in a healthcare setting
- Demonstrated excellence in leading professionals toward outcomes in support of strategic goals
- Experience serving as an EHS technical resource or program manager
- Demonstrated understanding of product and safety profiles
- Self-motivated, self-directing, strong attention to detail and execution
- Relevant working experience
3
Skills For Global Regulatory Relations Group Central Team Operations & Program Manager Resume
- Regulatory experience supporting IDE clinical studies
- Experience operationalizing privacy compliance frameworks
- Experience working cross functionally on projects as a manager and individual contributor
- Experience in implementation of work streams to deliver commercial solutions
- Experience in FDA regulated fields
- Average of 3 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
- Experience in quality assurance for operational and distribution workflow
- Well versed and experienced in Agile methodologies especially Scrum
- Fostering an open environment with constructive problem-solving and proactive issue and risk management
4
Skills For Regulatory Labeling Program Manager Resume
- Ensuring compliance with new and changing medical device regulations
- Planning and monitoring on the project
- Managing successful programs certification (MSP) , PMP (PMI), BCM
- Manage stakeholders, building of bridges, opening doors
- Extensive set of tools to drive your career, , free training and coaching
- Review key deliverables across testing pods for consistency (e.g. sampling results, audit packages, observations, etc.)
- Work with Global Regulatory Portfolio Leaders to translate strategy into actionable plans for obtaining and maintaining crop protection product registrations
5
Skills For Program Manager, Commercial Regulatory Resume
- Expert in managing high complexity programs or product areas within a large global organisation
- Lead the operating group regulatory structure, committee and/or council.
- Collaborates with entity quality leadership and staff to address potential vulnerabilities, ensure regulatory compliance and promote leading practice.
- Participates in mock surveys at sister hospitals. Also participates in mock surveys at other operating groups when supervisor approved.
- Change mgmt. training/certification is beneficial (changefirst, PCI)
- Facilitates team based improvement efforts, including tracers, SEAs, and other high reliability work groups
- Support correspondence with the FDA and interpretation of FDA comments. Including follow-on correspondence, such as resubmissions
- Executive reporting - produce SteerCo 4-blockers and status dashboards
- Coordinate onboarding of new associates and access to technical resources
6
Skills For Program Manager Quality & Regulatory Resume
- Develop project plans and track milestones for achieving on-time registration submissions and approvals
- Proactively anticipate and mitigate roadblocks and challenges for achieving registration goals
- Knowledge of programme/project management methodologies with in-depth knowledge of at least one methodology
- Ensure proficiency and efficacy of chapter/standard leaders.
- Oversee, verify and finalize annual regulatory compliance assessments.
- Coordinate all state licensure, federal and accreditation surveys. Participate in other regulatory reviews (i.e. Board of Pharmacy, Radiology, Lab, Food Services) as appropriate.
- Demonstrated significant knowledge and experience with health care regulations and health care compliance issues
- Understanding of regulatory environment in health care, and demonstrated ability to translate these into software
7
Skills For Regulatory Affairs Program Manager Resume
- Analyze compliance assessment data to determine regulatory priorities.
- Three years demonstrated leadership
- One to two years of Performance Improvement or Change Facilitation experience
- Experience in development of educational tools
- Exemplary skill with computer applications
- Reporting and risk mitigation; assess resource requirements for program and request funding approvals with relevant governance bodies; manage program budget
8
Skills For Program Manager of Regulatory Compliance Resume
- Reporting to the PS & Reg Operations LT, Global PS & Reg LT and Global R&D AOL Delivery team on program status, issues, risks or other related concerns
- Facilitate entity-level regulatory education.
- Leads proactive compliance assessments tracers, audits, direct observations, and interviews. Coordinate tracer teams.
- Coordinate the regulatory plan of activities.
- Coordinate plans that address actual or potential survey findings.
- Develop and manage regulatory dashboard(s).
- Serves as the entity point person for standards interpretation and clarification, and/or entity-based correspondence with regulatory agencies.
- Ensure policies, procedures and guidelines are compliant with regulations.
9
Skills For Global Regulatory Reporting Controls Oversight Transaction Review Program Manager Resume
- Participate in and lead resolution of system vulnerabilities.
- Participates in development of system education and tracer tools, and data repository needs.
- Past participation in regulatory activities
- Five years experience in a role requiring critical thinking and problem solving, managing complex projects that overlap between several clinical and/or business areas, and clearly communicating complex issues and concepts orally and in writing
- The Program Manager ensures that the program projects and program activities are properly organized, reported on and tracked in order to deliver the program outcomes and benefits
- Drive professional and effective project management to deliver scope, plan, resourcing, risk and quality management, reporting and delivery, compliance
- Ensure alignment overall / secure effective senior stakeholder engagement, sponsorship, intervention and approval
10
Skills For Accreditation & Regulatory Program Manager Resume
- Cultural awareness, international experience
- Proven ability to guide and motivate project managers and the PMO team
- Proven record in the delivery of projects and management of programs
- Ensure best-practice sharing across projects / provide and explains concepts / tools
- Support and lead the project teams to implementation their projects
- Day-to-day management of the program from ‘design’ to ‘closure’
- Lead assessment and mitigation, related to issues and risks escalated
List of Typical Responsibilities For a Regulatory Program Manager Resume
1
Responsibilities For Product Safety & Regulatory Program Manager Resume
- An in depth functional understanding of exchange traded derivatives and cleared OTC derivatives business processes and trade flows
- Knowledge of the global regulatory environment and statues impacting the cleared derivatives industry
- Maturity to lead cross-functional teams
- A proven delivery track record of working as a Program Manager in a fast-paced, multi-project environment with senior management face-offs and responsibility for resource management and project financials
- Familiarity with medical and anatomical terminology
- Successfully participate as project team member
- Technical and Business Expertise – Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area
2
Responsibilities For Global Regulatory Program Manager Resume
- Oversee post-survey procedures.
- Chance Management Expertise
- Three years of experience in a healthcare setting Three years demonstrated leadership One to two years of Project Management experience One to two years of Performance Improvement or Change Facilitation experience Past participation in regulatory activities Advanced skills in written and oral communication Experience in development of educational tools Exemplary skill with computer applications
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