Job DescriptionThe 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.
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.
QualificationsRequired Education: Bachelor's 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 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.
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.
Note: Higher education may compensate for years of experience
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
