Associate Director, RA CMC
AbbVie
August 13, 2026
Remote friendly (South San Francisco, CA)
United States
$141,500 - $268,500 USD yearly
Corporate Functions
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 (INDs/CTAs and amendments, new marketing applications, supplements/variations). Builds and maintains relationships across Regulatory Affairs, Operations, and R&D. Represents CMC on product development, Global Regulatory Product Teams, and Operations brand teams. Serves as liaison with regulatory agencies (e.g., FDA) regarding CMC matters.
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications/amendments, renewals annual reports, supplements/variations, and responses to regulatory information)
- Analyze and interpret information impacting regulatory decisions; seek technical support as needed
- Review and revise submissions to present data and strategy to agencies
- Develop strategies for CMC agency meetings; manage preparation and pre-meeting submission content; serve as point of contact
- Manage products and change control; analyze and approve manufacturing change requests
- Represent CMC regulatory affairs on cross-functional project teams to maximize chances for first pass approval
- Stay current on regulatory procedures/changes; analyze legislation/regulation/guidance
- Develop, implement, and document RA CMC policies and procedures; lead RA CMC initiatives
- Train, develop, and mentor individuals (may include supervisory responsibilities)
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field
- Preferred: Relevant advanced degree; certification a plus
- Required: 8 years pharmaceutical experience with 3+ years demonstrated leadership
- Preferred: 10 years pharmaceutical experience including 5+ years regulatory affairs or 5+ years in Discovery/R&D/Manufacturing
- Experience developing global regulatory strategies; working with Health Authorities
- Experience in complex matrix environments; strong oral and written communication
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications/amendments, renewals annual reports, supplements/variations, and responses to regulatory information)
- Analyze and interpret information impacting regulatory decisions; seek technical support as needed
- Review and revise submissions to present data and strategy to agencies
- Develop strategies for CMC agency meetings; manage preparation and pre-meeting submission content; serve as point of contact
- Manage products and change control; analyze and approve manufacturing change requests
- Represent CMC regulatory affairs on cross-functional project teams to maximize chances for first pass approval
- Stay current on regulatory procedures/changes; analyze legislation/regulation/guidance
- Develop, implement, and document RA CMC policies and procedures; lead RA CMC initiatives
- Train, develop, and mentor individuals (may include supervisory responsibilities)
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field
- Preferred: Relevant advanced degree; certification a plus
- Required: 8 years pharmaceutical experience with 3+ years demonstrated leadership
- Preferred: 10 years pharmaceutical experience including 5+ years regulatory affairs or 5+ years in Discovery/R&D/Manufacturing
- Experience developing global regulatory strategies; working with Health Authorities
- Experience in complex matrix environments; strong oral and written communication