Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
AbbVie
August 12, 2026
Remote friendly (Waltham, MA)
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, 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.
- 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 product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and maximize first-pass approval.
- Stay current on regulatory procedures and climate; analyze legislation/regulations/guidance and provide analysis to the organization.
- Develop, implement, and document RA CMC policies and procedures; participate in internal initiatives and represent CMC in cross-functional project initiatives to drive efficiencies.
- Hybrid work schedule: 3 days in office & 2 days remote (Waltham, MA or Lake County, IL HQ).
Qualifications:
- Bachelor’s Degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field. Preferred: relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience. Preferred: 10 years including 5+ years in regulatory affairs or 5+ years in Discovery/R&D or Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- 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.
- 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 product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and maximize first-pass approval.
- Stay current on regulatory procedures and climate; analyze legislation/regulations/guidance and provide analysis to the organization.
- Develop, implement, and document RA CMC policies and procedures; participate in internal initiatives and represent CMC in cross-functional project initiatives to drive efficiencies.
- Hybrid work schedule: 3 days in office & 2 days remote (Waltham, MA or Lake County, IL HQ).
Qualifications:
- Bachelor’s Degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field. Preferred: relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience. Preferred: 10 years including 5+ years in regulatory affairs or 5+ years in Discovery/R&D or Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- 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.