Director, RA CMC
AbbVie
July 01, 2026
Remote friendly (Irvine, CA)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Job Description
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies for first pass approvals. Develops and manages content strategy for regulatory submissions (INDs/CTAs and amendments, new marketing applications, supplements/variations). Builds relationships across Regulatory Affairs, Operations, and Research & Development (R&D). Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice. Serves as liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
- Prepares CMC regulatory product strategies; manages regulatory submissions (IND/CTA, amendments, marketing authorizations, renewals/annual reports, supplements/variations) and may lead a global RA CMC team.
- Advises internal personnel on regulatory strategies; provides strategic advice to RA, R&D, and Operations.
- Reviews and revises submission documentation; devises strategies for complex scenarios and timelines.
- Develops strategies for CMC agency interactions; prepares meeting requests/information packages; leads CMC discussions with health authorities; drives risk-based change planning with Manufacturing Operations.
- Manages products and change control; analyzes and approves manufacturing change records.
- Represents RA CMC on cross-functional teams; negotiates and influences to maximize first pass approval.
- Stays current on regulatory procedures/changes; analyzes legislation/guidance; leads white papers and policies.
- Designs initiatives to drive business efficiencies and implements enterprise culture initiatives across RA CMC.
- Trains, develops, mentors individuals; may supervise; evaluates performance and supports career development.
Qualifications
- Required: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.
- Preferred: Relevant advanced degree; certification a plus.
- Required experience: 10 years biopharmaceutical experience with 3+ years enterprise leadership; 5+ years in RA or related exposure.
- Preferred experience: 10+ years biopharmaceutical RA/R&D/Operations, including 7+ years regulatory affairs.
- Experience developing and implementing global regulatory strategies.
- Ability to interface with government regulatory agencies.
- Successful leadership in a complex, matrix environment; strong business understanding; strong oral and written communication skills.
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies for first pass approvals. Develops and manages content strategy for regulatory submissions (INDs/CTAs and amendments, new marketing applications, supplements/variations). Builds relationships across Regulatory Affairs, Operations, and Research & Development (R&D). Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice. Serves as liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
- Prepares CMC regulatory product strategies; manages regulatory submissions (IND/CTA, amendments, marketing authorizations, renewals/annual reports, supplements/variations) and may lead a global RA CMC team.
- Advises internal personnel on regulatory strategies; provides strategic advice to RA, R&D, and Operations.
- Reviews and revises submission documentation; devises strategies for complex scenarios and timelines.
- Develops strategies for CMC agency interactions; prepares meeting requests/information packages; leads CMC discussions with health authorities; drives risk-based change planning with Manufacturing Operations.
- Manages products and change control; analyzes and approves manufacturing change records.
- Represents RA CMC on cross-functional teams; negotiates and influences to maximize first pass approval.
- Stays current on regulatory procedures/changes; analyzes legislation/guidance; leads white papers and policies.
- Designs initiatives to drive business efficiencies and implements enterprise culture initiatives across RA CMC.
- Trains, develops, mentors individuals; may supervise; evaluates performance and supports career development.
Qualifications
- Required: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.
- Preferred: Relevant advanced degree; certification a plus.
- Required experience: 10 years biopharmaceutical experience with 3+ years enterprise leadership; 5+ years in RA or related exposure.
- Preferred experience: 10+ years biopharmaceutical RA/R&D/Operations, including 7+ years regulatory affairs.
- Experience developing and implementing global regulatory strategies.
- Ability to interface with government regulatory agencies.
- Successful leadership in a complex, matrix environment; strong business understanding; strong oral and written communication skills.