Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
AbbVie
June 30, 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 responses to regulatory information.
- Analyze and interpret information impacting regulatory decisions; seek expert technical support as needed.
- Review and revise submissions to present data and strategy effectively to regulatory agencies.
- Respond to global regulatory information requests.
- Develop strategies for CMC agency meetings; manage meeting preparation and pre-meeting submission content.
- Manage product and change control in line with regulations and company policies; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on product development, Global Regulatory Product Teams, and Operations brand teams; negotiate and influence cross-functional teams to maximize first-pass approval chances.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide recommendations.
- Develop, implement, and document RA CMC policies/procedures; participate in internal initiatives and cross-functional projects to drive efficiencies.
- Hybrid schedule: 3 days in office and 2 days remote (Waltham, MA or Lake County, IL).
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related field.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
- Note: Higher education may compensate for years of experience.
Responsibilities:
- Prepare CMC regulatory product strategies and manage regulatory submissions (new applications, 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 submissions to present data and strategy effectively to regulatory agencies.
- Respond to global regulatory information requests.
- Develop strategies for CMC agency meetings; manage meeting preparation and pre-meeting submission content.
- Manage product and change control in line with regulations and company policies; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on product development, Global Regulatory Product Teams, and Operations brand teams; negotiate and influence cross-functional teams to maximize first-pass approval chances.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide recommendations.
- Develop, implement, and document RA CMC policies/procedures; participate in internal initiatives and cross-functional projects to drive efficiencies.
- Hybrid schedule: 3 days in office and 2 days remote (Waltham, MA or Lake County, IL).
Qualifications:
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related field.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
- Note: Higher education may compensate for years of experience.