Associate Director, RA CMC
AbbVie
4 months ago
Remote friendly (Irvine, CA)
United States
Operations
Purpose
- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies and manages content strategy for regulatory submissions to enable first-pass approvals. Serves as a liaison to regulatory agencies (e.g., FDA) on CMC matters and represents CMC on cross-functional teams.
Responsibilities
- Prepare and manage CMC 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 submissions to effectively present data and strategy.
- Develop and manage strategy for CMC agency meetings; prepare and own pre-meeting submission content as point of contact.
- Manage product and change control; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on assigned projects; negotiate/influence to maximize first-pass approval likelihood.
- Stay current on regulatory procedures and changes; analyze legislation/regulations/guidance and provide organizational input.
- Develop, implement, and document RA department policies/procedures; lead internal RA CMC initiatives.
- Partner with other functions on project initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include supervisory responsibilities).
Qualifications
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field.
- Required Experience: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred: Relevant advanced degree; 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing; global regulatory strategy experience; experience with Health Authorities.
- Skills: Experience in complex matrix environments; strong oral and written communication.
Benefits (as stated)
- Paid time off (vacation/holidays/sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.
- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies and manages content strategy for regulatory submissions to enable first-pass approvals. Serves as a liaison to regulatory agencies (e.g., FDA) on CMC matters and represents CMC on cross-functional teams.
Responsibilities
- Prepare and manage CMC 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 submissions to effectively present data and strategy.
- Develop and manage strategy for CMC agency meetings; prepare and own pre-meeting submission content as point of contact.
- Manage product and change control; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on assigned projects; negotiate/influence to maximize first-pass approval likelihood.
- Stay current on regulatory procedures and changes; analyze legislation/regulations/guidance and provide organizational input.
- Develop, implement, and document RA department policies/procedures; lead internal RA CMC initiatives.
- Partner with other functions on project initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include supervisory responsibilities).
Qualifications
- Required: Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field.
- Required Experience: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred: Relevant advanced degree; 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing; global regulatory strategy experience; experience with Health Authorities.
- Skills: Experience in complex matrix environments; strong oral and written communication.
Benefits (as stated)
- Paid time off (vacation/holidays/sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.