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About the Role

Develop and advocate for strategic positions on CMC regulatory issues, impacting AbbVie's portfolio through cross-functional collaboration and serving as a scientific/technical resource within RA CMC.

Responsibilities

• Deliver strategic CMC regulatory insights and guidance to cross-functional stakeholders.
• Lead data-driven decision-making using internal and external regulatory databases.
• Oversee development and updating of regulatory CMC process documents, templates, and knowledge resources.
• Influence cross-functional internal stakeholders and drive alignment on regulatory expectations.
• Collaborate with RA CMC regional SMEs to monitor and address global regulatory CMC trends.
• Advise on critical regulatory submissions and cross-functional CMC initiatives.
• Advocate with regulatory agencies, industry groups, and external stakeholders.
• Champion AI implementation for CMC regulatory applications and lead internal assessment of emerging CMC topics.
• Lead benchmarking, contribute to industry publications and forums, and drive review of draft CMC guidances.

Requirements

• 12-plus years biopharmaceutical experience with at least 8-plus years in regulatory affairs and 5-plus years demonstrated enterprise leadership.
• 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.
• 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.

Skills

• Scientific/technical resource within RA CMC
• CMC regulatory policy
• Regulatory CMC
• AI implementation for CMC regulatory applications
• Emerging CMC topics
• Global CMC regulatory requirements and guidelines
• Influencing skills
• Communication skills
• Negotiation skills
• Advocacy skills
• Relationship building
• Strategic thinking
• CMC regulatory policy changes
• External presence
• Industry forums
• Conference presentations
• Publications
• Business understanding
• Complex and matrix environment experience
• Global regulatory strategies for CMC

Experience Level

• 12-plus years biopharmaceutical experience
• 8-plus years in regulatory affairs
• 5-plus years demonstrated enterprise leadership
• 15-plus years biopharmaceutical experience
• 12-plus years in regulatory affairs or R&D, or Manufacturing

Education Level

• Bachelor’s degree in pharmacy, biology, chemistry, Engineering or related subjects.
• Advanced degree (M.S., Ph.D or Pharm.D) in a scientific, health, or business discipline.
• Regulatory certifications are a plus.

Salary/Compensations

• USD 182000 - USD 346000 - yearly

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible to participate in our long-term incentive programs

About the Company

• AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
• We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Equal Opportunity

• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
• Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html