job posting · smartrecruiters
AbbVie Inc.: Associate Director, RA CMC
Observed on the employer’s careers system, last checked 2026-09-09.
- Employer
- AbbVie Inc.
- Location
- Irvine
- Category
- Other
- Posted
- 2026-09-08
- Careers system
- smartrecruiters
- Observed
- 2026-09-09
Role description
Verbatim from the employer’s posting, rendered as plain text.
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Responsibilities Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions,…
Provenance
3743990015122366