Associate Director, RA CMC
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
Corporate Functions
Purpose
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies and manages regulatory submission content to enable first-pass approvals. Acts as liaison with regulatory agencies (e.g., FDA) on CMC matters and represents CMC on cross-functional teams.
Responsibilities
- Prepare and manage CMC regulatory product strategies and 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 strategies for agency meetings; manage preparation, pre-meeting submission content, and serve as point of contact.
- 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 for assigned projects; negotiate and influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation, regulation, and guidance and provide insights to the organization.
- Develop, implement, and document regulatory affairs policies/procedures; lead internal RA CMC initiatives.
- Coordinate with other functional areas on project initiatives to drive efficiencies.
- Train, develop, and mentor individuals; may include formal supervisory responsibilities.
Qualifications
- Required Education: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related field.
- Preferred Education: Relevant advanced degree; certification a plus.
- Required Experience: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred Experience: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing successful global regulatory strategies; experience working with Health Authority.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
Benefits (if offered)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies and manages regulatory submission content to enable first-pass approvals. Acts as liaison with regulatory agencies (e.g., FDA) on CMC matters and represents CMC on cross-functional teams.
Responsibilities
- Prepare and manage CMC regulatory product strategies and 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 strategies for agency meetings; manage preparation, pre-meeting submission content, and serve as point of contact.
- 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 for assigned projects; negotiate and influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation, regulation, and guidance and provide insights to the organization.
- Develop, implement, and document regulatory affairs policies/procedures; lead internal RA CMC initiatives.
- Coordinate with other functional areas on project initiatives to drive efficiencies.
- Train, develop, and mentor individuals; may include formal supervisory responsibilities.
Qualifications
- Required Education: Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related field.
- Preferred Education: Relevant advanced degree; certification a plus.
- Required Experience: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred Experience: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing successful global regulatory strategies; experience working with Health Authority.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.
Benefits (if offered)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.