Director of RA CMC Knowledge Management & Strategy

AbbVie•South San Francisco, CA

1d•$182,000 - $346,000

About The Position

The Knowledge Management and Strategic Initiatives role will develop & advocate strategic positions for CMC regulatory/CMC issues with cross functional internal stakeholders and on behalf of AbbVie in key areas that will meaningfully impact acceleration of AbbVie’s portfolio. This can be accomplished through active engagement with internal cross-functional and external groups and serving as a scientific/technical resource within RA CMC that provides guidance/direction to our staff to develop robust product strategies that integrate CMC regulatory policy and expectations.

Requirements

Bachelor’s degree in pharmacy, biology, chemistry, Engineering or related subjects.
12-plus years biopharmaceutical experience with at least 8-plus years in regulatory affairs and 5-plus years demonstrated enterprise leadership (as described above) including:
Drug Development/CMC experience is most relevant.
Strong knowledge of global CMC regulatory requirements and guidelines.
Excellent influencing and communication, negotiation, and advocacy skills.
Proven ability to build and maintain relationships with regulatory authorities and industry stakeholders.
Strategic thinker with the ability to influence and drive CMC regulatory policy changes.
Strong external presence established through industry forums, conference presentations, or publications.
Good understanding of the business/enterprise.
Experience working in complex and matrix environment.
Experience developing and implementing successful and innovative global regulatory strategies for CMC.

Nice To Haves

Advanced degree (M.S., Ph.D or Pharm.D) in a scientific, health, or business discipline.
Regulatory certifications are a plus.
15-plus years biopharmaceutical experience including: 12-plus years in regulatory affairs or R&D, or Manufacturing and/or direct experience working at FDA or with other major global health authorities or at CMC focused trade associations.
Higher education may compensate for years of experience

Responsibilities

Deliver strategic CMC regulatory insights and guidance to cross functional stakeholders by sharing expertise, monitoring industry trends, and implementing emerging regulatory expectations.
Lead data-driven decision-making by leveraging internal and external regulatory databases to analyze trends and optimize submission and response strategies.
Oversee development and continual updating of regulatory CMC process documents, templates, and knowledge resources to ensure alignment with current requirements and best practices.
Influence cross functional internal stakeholders and drive alignment by implementing regulatory expectations through updated position papers and policies, and ongoing stakeholder engagement.
Collaborate with RA CMC regional SMEs to monitor and address emerging regulatory CMC trends across global markets, ensuring proactive regulatory compliance, knowledge sharing and maintenance of AbbVie’s Reg Requirements Portal.
Advise on critical regulatory submissions and cross-functional CMC initiatives, ensuring content consistency and best practices across programs.
Advocate with regulatory agencies, industry groups, and external stakeholders to drive a CMC regulatory environment that fosters innovation and patient access.
Champion AI implementation for CMC regulatory applications and lead internal assessment of emerging CMC topics, guiding sub-teams to effective outcomes.
Lead benchmarking, contribute to industry publications and forums, and drive review and commentary on draft CMC guidances to influence regulatory best practices.