Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
AbbVie
August 12, 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; manage submissions (new applications, amendments, renewals annual reports, supplements/variations) and respond to regulatory information
- Analyze and interpret information impacting regulatory decisions; obtain 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 and manage preparation for CMC agency meetings, including pre-meeting submissions content
- Manage products and change control; analyze and approve manufacturing change requests
- Represent CMC regulatory affairs on cross-functional teams to negotiate, influence, and provide strategic advice to maximize first-pass approval
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide analysis
- Develop, implement, and document RA CMC policies and procedures; participate in internal initiatives and drive efficiencies across functions
- Hybrid schedule: 3 days in office and 2 days remote (Waltham, MA and Lake County, IL HQ)
Significant work activity: Continuous sitting >2 consecutive hours in an 8-hour day.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field; relevant advanced degree preferred; certification a plus
- 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 global regulatory strategies
- Experience in complex/matrix environments
- Strong oral and written communication skills
Benefits (explicitly stated): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.
Responsibilities:
- Prepare CMC regulatory product strategies; manage submissions (new applications, amendments, renewals annual reports, supplements/variations) and respond to regulatory information
- Analyze and interpret information impacting regulatory decisions; obtain 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 and manage preparation for CMC agency meetings, including pre-meeting submissions content
- Manage products and change control; analyze and approve manufacturing change requests
- Represent CMC regulatory affairs on cross-functional teams to negotiate, influence, and provide strategic advice to maximize first-pass approval
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance and provide analysis
- Develop, implement, and document RA CMC policies and procedures; participate in internal initiatives and drive efficiencies across functions
- Hybrid schedule: 3 days in office and 2 days remote (Waltham, MA and Lake County, IL HQ)
Significant work activity: Continuous sitting >2 consecutive hours in an 8-hour day.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field; relevant advanced degree preferred; certification a plus
- 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 global regulatory strategies
- Experience in complex/matrix environments
- Strong oral and written communication skills
Benefits (explicitly stated): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.