Associate Director, RA CMC
AbbVie
August 13, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Corporate Functions
Associate Director, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications/amendments, renewals annual reports, supplements, variations) and respond to regulatory information.
- Analyze and interpret information impacting regulatory decisions; seek expert technical support as needed.
- Review and revise regulatory submissions to present data and strategy effectively to regulatory agencies.
- Develop CMC agency-meeting strategies; manage preparation and pre-meeting submission content; serve as point of contact for agency meetings.
- Manage products and change control; analyze and approve manufacturing change requests in line with regulations and company policies.
- Represent CMC Regulatory Affairs on product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiate and influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide analysis to the organization.
- Develop, implement, and document RA department policies and procedures; lead internal RA CMC initiatives.
- Represent CMC Regulatory Affairs on cross-functional project initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include formal supervisory responsibilities).
Qualifications:
- Required: Bachelor’s Degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing global regulatory strategies; experience working with Health Authority.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions: Not provided.
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications/amendments, renewals annual reports, supplements, variations) and respond to regulatory information.
- Analyze and interpret information impacting regulatory decisions; seek expert technical support as needed.
- Review and revise regulatory submissions to present data and strategy effectively to regulatory agencies.
- Develop CMC agency-meeting strategies; manage preparation and pre-meeting submission content; serve as point of contact for agency meetings.
- Manage products and change control; analyze and approve manufacturing change requests in line with regulations and company policies.
- Represent CMC Regulatory Affairs on product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiate and influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide analysis to the organization.
- Develop, implement, and document RA department policies and procedures; lead internal RA CMC initiatives.
- Represent CMC Regulatory Affairs on cross-functional project initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include formal supervisory responsibilities).
Qualifications:
- Required: Bachelor’s Degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing global regulatory strategies; experience working with Health Authority.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions: Not provided.