Senior Director, Sciences & Regulatory Affairs

17 Jul, 2021

Jobs

Senior Director, Sciences & Regulatory Affairs

Association for Accessible Medicines
Washington, DC

Job Summary:
The Senior Director, Sciences & Regulatory Affairs, in partnership with the SVP, Sciences & Regulatory
Affairs and other members of the Sciences & Regulatory Affairs Team, is responsible for the
development and oversight of the Association for Accessible Medicines’ (AAM) Sciences & Regulatory
Affairs (SRA) initiatives.
Initiatives will be achieved by working with members of the Sciences and Regulatory Affairs Working
Group (SRAWG), other Sciences & Regulatory Affairs personnel from member-companies, AAM SRA
staff, and staff across all AAM functional groups. The role is also responsible for member
communications and training opportunities for SRA initiatives.
Essential Duties and Responsibilities:
• Lead assigned working groups to achieve identified objectives through efforts of member company
representatives, AAM staff, and consultants.
• Maintain relationships with key personnel at FDA, USP, and other relevant stakeholders on behalf of
AAM.
• Manage activities across multiple SRA working groups and initiatives as appropriate to maximize
impact; oversee activities of other SRA staff as necessary.
• Manage activities of SRA across all AAM functional groups as assigned and required.
• Manage the preparation and implementation of SRA-hosted conferences and education workshops
and webinars. Responsibilities include but are not limited to:
▪ Manage and coordinate the preparation of all associated materials,
▪ Lead planning committees as assigned, ensure member-company, FDA, USP, and
other relevant stakeholders input and participation,
▪ Work with panelists and speakers to coordinate message points, resolve issues and
concerns to assure a successful event.
2
• In collaboration with the VP, Sciences & Regulatory Affairs, contribute to the management of
Member Sciences & Regulatory Initiative (MS&RI). Duties include but are not limited to collecting
requests and recommendations from members for issues and projects, facilitating discussion and
actions between member-companies and FDA.
• 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.
• Advanced knowledge of the regulatory process and regulatory issues of the generics and
biosimilars industry.
• Ability to be diplomatic, resourceful, persuasive, effective negotiation skills.
• Exceptional organizational and project management skills to lead working groups for timely
implementation of projects involving multiple functions and external resources.
• 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
work standards.
• 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 demonstrate business-savvy judgement.
• Ability to take responsibility for assignments 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 oral communication skills.
• Exceptional interpersonal skills, a focused listener.
• Exhibit a positive attitude and professional demeanor.
• Exhibit a high degree of personal initiative.
Education and Experience Requirements:
• Bachelor’s degree in science-related field, required; advanced degree in science, preferred.
• 8+ years of experience in pharmaceutical science related role, with 5+ years in government
regulatory agency (FDA) and/or a pharmaceutical industry regulatory department required.
• Experience with ANDA dossier development and filing, preferred.
• Project management experience and/or supervisory experience, required.
3
Physical Demands: The physical demands described here are representative of those that must
be met by an employee to successfully perform the essential functions of the job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential
functions.
• None
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
functions.
• Standard office environment
Travel: up to 25% domestic travel

Please email jobs@accessiblemeds.org to submit a resume and cover letter.

Job posted: 2021-07-17