The Senior Vice President of Regulatory & Scientific Affairs is responsible for developing policies, influencing regulations, advising member companies and setting strategic direction for regulatory and scientific issues affecting the CHPA membership in the United States, the largest market in the world for consumer healthcare products. This role helps to promote a constructive regulatory environment for the industry at both the federal and state levels of government. The incumbent will serve as the primary liaison with the FDA to influence and interpret regulations for OTC drugs and consumer medical devices, with secondary responsibility for dietary supplement regulatory work. They will advise and update member companies, association departments, and ingredient task groups on regulations and scientific issues impacting product development, manufacturing, and marketing. They will work to defend ingredients’ safety, efficacy, and quality standards. Moreover, the position oversees regulatory surveillance at the global level via engagement with the Global Self-Care Federation and contributes to public/media communications on regulatory, scientific, and safety matters.
The Senior Vice President of Regulatory & Scientific Affairs also collaborates and interacts across association departments, including participating in membership development activities and supporting government affairs in the analysis and prioritization of legislation. The role also supervises department staff and develops and manages the department budget while participating in overall association management as a member of the CHPA Senior Management Team (SMT).
The Senior Vice President of Regulatory & Scientific Affairs reports to the President & CEO and manages a team of four CHPA staff, along with outside consultants.
The SVP has the following direct reports:
Two Vice Presidents of Regulatory & Scientific Affairs
One Director/Senior Director, Quality Assurance & Technical Affairs
One Administrative Assistant will be a direct report to the Senior Vice President of Regulatory & Scientific Affairs.
Strategy & Policy
Leads the development of association regulatory priorities and oversees strategies to influence interpretation and administration of federal and state regulations affecting the U.S. consumer healthcare industry.
Works with member companies through committees to develop plans to assist the President and Board of Directors in setting policy and direction on key regulatory and scientific issues. Regularly engage with FDA and other federal or state regulatory agencies on regulatory, scientific, and policy issues on behalf of CHPA members.
Develops and executes strategy and prepares commentary submission documents used to support the Association’s position on scientific and regulatory matters to federal and state agencies and NGOs, such as USP.
Scientific Issues Management
Leads and oversees regulatory and science-focused task groups related to specific ingredients or issues, develops action plans to resolve issues, and sets timelines to complete work. Collects and disseminates pertinent regulatory and scientific information to membership and allied associations.
Formulates strategic plans and programs of work, including milestones, budgets, and timelines for committees (Regulatory & Scientific Affairs, Consumer Medical Devices, Quality & Manufacturing Committee, and ingredient task groups.
Provides regulatory and scientific advice to member companies on protocols necessary for interacting with FDA Advisory Committees, OTC Monograph reform, Rx-OTC switch, brand naming, labeling, product testing, market research, safety issues, product stewardship, etc.
Represent the Association and industry as a scientific/regulatory spokesperson.
Prepares and directs spending and manages the department’s annual budget.
Provides leadership and support to department staff, conducting ongoing coaching and feedback on strengths and opportunities for growth. Conducts regular evaluations of staff and monitors work plans, goals, and timelines in completing assignments.
Develop the regulatory/technical perspective for CHPA management to ensure quality outcomes on regulatory and scientific issues and opportunities. Promotes a consistent, adequate standard on regulatory and technical issues for staff, member companies, and constituent stakeholders. Maintains CHPA website for regulatory/scientific communications.
Plans and executes major workshops (annual regulatory, scientific, and quality conference, roundtables w/ FDA) and scientific meetings (FDA dialog meetings) for Association members to foster working relationships with FDA and government regulatory and scientific groups.
Oversees CHPA’s participation and representation on the Regulatory Affairs Committee of the Global Self-Care Federation.
Closely collaborates and provides content and speaker direction with the Technical Meetings and Logistics Planner for the annual Regulatory, Scientific & Quality Conference.
Builds and maintains constructive lines of communication with FDA officials by holding regular meetings to build rapport and understanding of CHPA and the industry.
Conducts periodic conferences with FDA personnel to provide education on industry practices, issues, and constraints to positively influence FDA policies and actions.
Ph.D., MD, or PharmD is strongly preferred, along with an ability to read and interpret the regulatory landscape to effectuate change to minimize and mitigate the unintended consequences of future scientific and regulatory policy development by the FDA. A lawyer with extensive experience counseling clients and influencing FDA regulations and policy will be considered.
15+ years of relevant pharmaceutical experience working with OTC products or similar FDA experience.
Experience with dietary supplements and consumer medical devices is highly desirable.
Required Skills & Personal Attributes
Ability to understand and evaluate complex scientific data.
Lead and nurture a high-performing team through effective coaching, mentorship, and skill development, fostering individual growth and collective success.
Detail-oriented with the ability to effectively communicate scientific information, concepts, and conclusions to a variety of groups, including the FDA, academicians, scientists from member companies, CHPA board members, and CHPA staff, in both technical and non-technical language.
Ability to apply verbal and written communication skills, including the ability to address an array of audiences and a range of environments and gain the respect and confidence of multiple groups quickly.
Demonstrates exceptional prioritization skills by strategically organizing tasks and objectives based on their importance and impact on overall goals.
Ability to build effective and trusting working relationships with member companies and the FDA.
Ability to understand divergent viewpoints and develop consensus positions among groups.
Final authority on department work plans and execution timing.
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