Director, RA CMC
AbbVie
July 01, 2026
Remote friendly (North Chicago, IL)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Job Description
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies to enable first pass approvals; develops submission content strategy (IND/CTA and amendments, marketing applications, supplements/variations); builds relationships across Regulatory Affairs, Operations, and R&D; represents RA CMC on product development/life-cycle teams to negotiate and provide strategic advice; serves as liaison with regulatory agencies (e.g., FDA) on CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
- Prepare and manage CMC regulatory product strategies and submissions (IND/CTA, amendments, marketing authorizations, renewals, annual reports, supplements/variations) or lead global RA CMC teams.
- Advise peers and management on regulatory strategies across RA, R&D, and Operations; seek expert support as needed.
- Review/revise regulatory documentation; devise strategies for complex scenarios and timelines.
- Lead CMC discussions with health authorities; manage agency meeting requests and information packages; drive risk-based change planning with Manufacturing Operations.
- Manage product and manufacturing change control; analyze/approve manufacturing change records.
- Represent RA CMC on product development/Global Regulatory Product/Operations Product teams; influence to maximize first pass approval.
- Track regulatory procedures and changes; analyze guidance/legislation; lead white papers/policies.
- Design initiatives for business efficiencies; ensure enterprise culture implementation across RA CMC.
- Train, develop, mentor staff; may include supervisory responsibilities; 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 in biopharmaceutical RA/R&D/Operations including 7+ years regulatory affairs.
- Experience developing/implementing global regulatory strategies; strong ability interfacing with government agencies.
- Demonstrated success leading in complex, matrix environments; strong business understanding.
- Strong oral and written communication skills.
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies to enable first pass approvals; develops submission content strategy (IND/CTA and amendments, marketing applications, supplements/variations); builds relationships across Regulatory Affairs, Operations, and R&D; represents RA CMC on product development/life-cycle teams to negotiate and provide strategic advice; serves as liaison with regulatory agencies (e.g., FDA) on CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
- Prepare and manage CMC regulatory product strategies and submissions (IND/CTA, amendments, marketing authorizations, renewals, annual reports, supplements/variations) or lead global RA CMC teams.
- Advise peers and management on regulatory strategies across RA, R&D, and Operations; seek expert support as needed.
- Review/revise regulatory documentation; devise strategies for complex scenarios and timelines.
- Lead CMC discussions with health authorities; manage agency meeting requests and information packages; drive risk-based change planning with Manufacturing Operations.
- Manage product and manufacturing change control; analyze/approve manufacturing change records.
- Represent RA CMC on product development/Global Regulatory Product/Operations Product teams; influence to maximize first pass approval.
- Track regulatory procedures and changes; analyze guidance/legislation; lead white papers/policies.
- Design initiatives for business efficiencies; ensure enterprise culture implementation across RA CMC.
- Train, develop, mentor staff; may include supervisory responsibilities; 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 in biopharmaceutical RA/R&D/Operations including 7+ years regulatory affairs.
- Experience developing/implementing global regulatory strategies; strong ability interfacing with government agencies.
- Demonstrated success leading in complex, matrix environments; strong business understanding.
- Strong oral and written communication skills.