Associate Director, RA CMC
AbbVie · Irvine, CA
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Role summary
Associate Director in Regulatory Affairs for Chemistry, Manufacturing and Controls at a pharmaceutical company. Develops CMC regulatory strategies, manages submissions to regulatory agencies, and collaborates across internal teams to support product approvals. Based in Irvine, CA.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on SmartRecruiters, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field
- 8 years pharmaceutical industry experience with minimum 3 years in demonstrated leadership role
- Experience developing and implementing global regulatory strategies with health authorities
- Experience in complex, matrix organizational environments
- Strong oral and written communication skills
- Advanced degree or relevant certification preferred
What you'll be doing
- Develop CMC regulatory product strategies and manage regulatory submissions including INDs, CTAs, amendments, and marketing applications
- Analyze regulatory data and information; provide expert guidance on CMC matters to internal and external partners
- Lead preparation for regulatory agency meetings and serve as primary contact with agencies such as FDA
- Review and approve manufacturing change control requests and evaluate regulatory compliance
- Mentor and develop regulatory affairs staff and lead departmental initiatives and process improvements
Privacy & handoff
This role links to AbbVie's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.