Latest Public Affairs News & Articles
Vice President, Sciences & Regulatory Affairs
Job Summary: The VP, Sciences & Regulatory Affairs creates and implements strategic plans to drive
key Sciences & Regulatory Affairs (SRA) priorities. The position leads AAM Working Groups and Task
Forces in all aspects of GDUFA and BsUFA from negotiations to implementation, as well as key topic
initiatives as raised by FDA and/or member companies. The VP, Sciences & Regulatory Affairs is the
primary point of contact to all relevant domestic regulatory agencies and member company regulatory
Essential Duties and Responsibilities:
• Lead the development of strategy to achieve desired outcomes on AAM priorities, FDA and USP
initiatives and member company requests.
o Define and operationalize initiatives arising from FDA activity and member-company issues.
• Oversee consultants and member company representatives as assigned to specific projects.
• Lead the Member Sciences & Regulatory Affairs Initiatives.
o Create strategy, frame industry position, and document implementation plans
o Convene SMEs from member companies to build strategy, define plans and address issues.
o Facilitate discussion and action of members and FDA, convening discussions as
appropriate, and guide staff/consultant activity to achieve results.
o Collect and evaluate requests and recommendations from members for issues and projects.
• Lead all GDUFA and BsUFA activities including negotiations, implementation, and episodic
• Serve as the primary liaison and point of contact for AAM and member companies
representatives to relevant agencies and organizations including FDA, USP and global
regulators. Oversee the activity of all working groups and task forces being coordinated by SRA staff to
ensure strategy is consistent with AAM priorities.
• Develop/create all SRA-hosted conferences and workshops; incorporate member company and
FDA/USP input. Responsibilities include but are not limited to guiding speaker/panel selection,
serve as the lead for FDA, USP and member company representative on the planning
committee, and supervise all staff and consultants in preparation for events.
• Coordinate information needs of member companies with FDA, envisioning and implementing
regular communications and education opportunities on new initiatives, trends and issues.
• Perform other duties as assigned consistent with the goals of AAM.
Qualifications: To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are representative of the
knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
• Extensive knowledge of the regulatory process and regulatory issues of the generic
• Ability to be diplomatic, resourceful and persuasive.
• Ability to anticipate challenges and effectively resolve conflict by identifying opportunities.
• Ability to work creatively and with flexibility in a fast-paced environment while maintaining high
• Ability to work independently as well as collaboratively with internal and external stakeholders, a
keen sense of protocol.
• Ability to prioritize and manage multiple initiatives simultaneously.
• Ability to take responsibility for assignments, develop a strategic vision and see them through
to a successful completion, with little oversight.
• Ability to develop rapport and engender trust, transparent.
• Ability to inspire and motivate constituents, build consensus.
• Ability to balance multiple requirements of internal and external constituents with a flexibility
and a steady temperament.
• Exceptional written and verbal communication skills.
• Exceptional organizational and project management skills for timely implementation of projects
involving multiple functions and external resources.
• Exceptional interpersonal skills, a focused listener.
• Exhibits a positive attitude and professional demeanor.
• Exhibits a high degree of personal initiative.
• Effective negotiation skills.
Education and Experience Requirements:
• Advanced degree in science-related field (i.e., Pharm.D. Ph.D., etc.), required.
• 10+ years of experience in science-related role with 5+ years in regulatory agency and/or
pharmaceutical regulatory organization, required.
• 3+ years of supervisory experience, required.
• Experience with ANDA development and filing preferred.
Work Environment: The work environment characteristics described here are representative of
those an employee encounters while performing the essential functions of the job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential
• Standard office environment
Travel: up to 25%
Please email firstname.lastname@example.org to submit a resume and cover letter.
Job posted: 2022-04-18