Director, RA CMC
AbbVie
July 01, 2026
Remote friendly (Waltham, MA)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Job Description:
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) develops CMC regulatory strategies, manages regulatory submissions, and leads/coordinates with internal and external partners to enable first-pass approvals. Serves as strategic liaison with regulatory agencies (e.g., FDA) on CMC matters. May include formal supervisory responsibilities and manages assigned projects.
Responsibilities:
- Prepare and manage CMC regulatory product strategies and submissions (IND/CTA, amendments, marketing authorizations, renewals, annual reports, supplements/variations) and may lead a global RA CMC team.
- Advise RA, R&D, and Operations peers/management on regulatory strategies; obtain expert technical support when needed.
- Review and revise submission documentation; devise strategies for complex scenarios and aggressive timelines.
- Plan and lead CMC agency interactions; manage meeting requests/information packages; drive risk-based change planning with Manufacturing Operations.
- Manage product/change control; analyze and approve manufacturing change records.
- Represent RA CMC on cross-functional product development and product teams; negotiate/influence to maximize first-pass approval.
- Monitor regulatory procedures/changes; analyze guidance and create white papers/policies.
- Design initiatives for business efficiencies and ensure enterprise culture initiatives across RA CMC.
- Train, develop, mentor; may supervise; evaluate performance and support career development.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.
- Preferred: relevant advanced degree; certification a plus.
- Required: 10+ years biopharmaceutical experience with 3+ years enterprise leadership; 5+ years in RA or related exposure.
- Preferred: 10+ years biopharmaceutical RA/R&D/Operations, including 7+ years regulatory affairs.
- Global regulatory strategy experience; ability to interface with government agencies; success in complex matrix environments; strong business understanding; strong oral and written communication.
Benefits (if part of posting): Comprehensive package including paid time off, medical/dental/vision, and 401(k); eligible for long-term incentive programs.
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) develops CMC regulatory strategies, manages regulatory submissions, and leads/coordinates with internal and external partners to enable first-pass approvals. Serves as strategic liaison with regulatory agencies (e.g., FDA) on CMC matters. May include formal supervisory responsibilities and manages assigned projects.
Responsibilities:
- Prepare and manage CMC regulatory product strategies and submissions (IND/CTA, amendments, marketing authorizations, renewals, annual reports, supplements/variations) and may lead a global RA CMC team.
- Advise RA, R&D, and Operations peers/management on regulatory strategies; obtain expert technical support when needed.
- Review and revise submission documentation; devise strategies for complex scenarios and aggressive timelines.
- Plan and lead CMC agency interactions; manage meeting requests/information packages; drive risk-based change planning with Manufacturing Operations.
- Manage product/change control; analyze and approve manufacturing change records.
- Represent RA CMC on cross-functional product development and product teams; negotiate/influence to maximize first-pass approval.
- Monitor regulatory procedures/changes; analyze guidance and create white papers/policies.
- Design initiatives for business efficiencies and ensure enterprise culture initiatives across RA CMC.
- Train, develop, mentor; may supervise; evaluate performance and support career development.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.
- Preferred: relevant advanced degree; certification a plus.
- Required: 10+ years biopharmaceutical experience with 3+ years enterprise leadership; 5+ years in RA or related exposure.
- Preferred: 10+ years biopharmaceutical RA/R&D/Operations, including 7+ years regulatory affairs.
- Global regulatory strategy experience; ability to interface with government agencies; success in complex matrix environments; strong business understanding; strong oral and written communication.
Benefits (if part of posting): Comprehensive package including paid time off, medical/dental/vision, and 401(k); eligible for long-term incentive programs.