Director of RA CMC Knowledge Management & Strategy

About the role

The Knowledge Management and Strategic Initiatives role will develop and 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 the 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.

Responsibilities

• Deliver strategic CMC regulatory insights and guidance to cross-functional stakeholders by sharing expertise, monitoring industry trends, and implementing emerging regulatory expectations.
• Leverage 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 guidance to influence regulatory best practices.

Qualifications

• Required Education: Bachelors degree in pharmacy, biology, chemistry, Engineering, or related subjects.
• PREFERRED Education: Advanced degree (M.S., Ph.D., or Pharm.D.) in a scientific, health, or business discipline.
• Regulatory certifications are a plus.
• Required Experience: 12-plus years biopharmaceutical experience with at least 8-plus years in regulatory affairs and 5-plus years of 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 environments.
• Experience developing and implementing successful and innovative global regulatory strategies for CMC.
• PREFERRED Experience: 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.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)