Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
AbbVie
June 30, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications and amendments, renewals annual reports, supplements/variations, and responses 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.
- Respond to global regulatory information requests.
- Develop strategies for CMC agency meetings; manage preparation and pre-meeting submission content.
- Manage products and change control; analyze and approve manufacturing change requests.
- Represent CMC Regulatory Affairs on cross-functional teams (product development, Global Regulatory Product Teams, Operations brand teams); negotiate/influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide recommendations.
- Develop, implement, and document RA CMC policies/procedures; participate in RA initiatives and cross-functional projects to drive efficiencies.
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related subject.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years regulatory affairs or 5+ years Discovery/R&D/Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience in complex matrix environments.
- Strong oral and written communication skills.
Benefits/Work schedule:
- Hybrid: 3 days in office & 2 days remote (Waltham, MA & Lake County, IL headquarters).
- Paid time off, medical/dental/vision insurance, and 401(k); eligible for long-term incentive programs.
Application instructions: Not provided in the text.
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications and amendments, renewals annual reports, supplements/variations, and responses 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.
- Respond to global regulatory information requests.
- Develop strategies for CMC agency meetings; manage preparation and pre-meeting submission content.
- Manage products and change control; analyze and approve manufacturing change requests.
- Represent CMC Regulatory Affairs on cross-functional teams (product development, Global Regulatory Product Teams, Operations brand teams); negotiate/influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide recommendations.
- Develop, implement, and document RA CMC policies/procedures; participate in RA initiatives and cross-functional projects to drive efficiencies.
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related subject.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years regulatory affairs or 5+ years Discovery/R&D/Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience in complex matrix environments.
- Strong oral and written communication skills.
Benefits/Work schedule:
- Hybrid: 3 days in office & 2 days remote (Waltham, MA & Lake County, IL headquarters).
- Paid time off, medical/dental/vision insurance, and 401(k); eligible for long-term incentive programs.
Application instructions: Not provided in the text.