Senior Manager, Global Regulatory Affairs, CMC
Jazz Pharmaceuticals
August 21, 2026
Remote friendly (California, United States)
United States
Corporate Functions
Brief Description:
- The Senior Manager, Regulatory Affairs Global CMC will manage registration and CMC regulatory support for commercial and/or development projects worldwide for biological products.
Essential Functions:
- Manage preparation/review of Module 2 and 3 CTD sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, briefing documents) for biological products.
- Support Global CMC regulatory strategy for commercial and late/early-stage development programs.
- Perform risk assessments; identify and communicate potential strategy risks to multi-disciplinary and Global Regulatory teams.
- Coordinate and submit regulatory agency responses; manage timelines to ensure approvals and development objectives.
- Serve as regulatory CMC representative for business partner meetings; contribute to regulatory agency meetings for CMC issues.
- Ensure regulatory compliance via change control, regulatory information management, and regulatory impact assessments.
- Maintain current regulatory product information to support product release; verify electronic publishing of submissions.
- Identify and support continuous improvement opportunities.
- Ensure compliance with company policies, procedures, and training expectations.
Required Knowledge/Skills:
- Strategic understanding and application of drug lifecycle regulations (preferably biological products).
- Solid CMC regulatory knowledge; ability to develop clear, well-argued positions.
- Experience with electronic CTD CMC documents (MAA, BLA, variations, responses, CTAs/INDs).
- Understanding of FDA, EMA, and ICH guidelines.
- Strong interpersonal skills working with internal teams and external partners/regulators.
Education/Licenses:
- BSc/BA with regulatory CMC or related experience.
- Written and verbal English communication.
Benefits (US, if applicable):
- Medical, dental, vision insurance; 401k; flexible paid vacation.
Application Instructions:
- If a current Jazz employee, apply via the Internal Career site.
- The Senior Manager, Regulatory Affairs Global CMC will manage registration and CMC regulatory support for commercial and/or development projects worldwide for biological products.
Essential Functions:
- Manage preparation/review of Module 2 and 3 CTD sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, briefing documents) for biological products.
- Support Global CMC regulatory strategy for commercial and late/early-stage development programs.
- Perform risk assessments; identify and communicate potential strategy risks to multi-disciplinary and Global Regulatory teams.
- Coordinate and submit regulatory agency responses; manage timelines to ensure approvals and development objectives.
- Serve as regulatory CMC representative for business partner meetings; contribute to regulatory agency meetings for CMC issues.
- Ensure regulatory compliance via change control, regulatory information management, and regulatory impact assessments.
- Maintain current regulatory product information to support product release; verify electronic publishing of submissions.
- Identify and support continuous improvement opportunities.
- Ensure compliance with company policies, procedures, and training expectations.
Required Knowledge/Skills:
- Strategic understanding and application of drug lifecycle regulations (preferably biological products).
- Solid CMC regulatory knowledge; ability to develop clear, well-argued positions.
- Experience with electronic CTD CMC documents (MAA, BLA, variations, responses, CTAs/INDs).
- Understanding of FDA, EMA, and ICH guidelines.
- Strong interpersonal skills working with internal teams and external partners/regulators.
Education/Licenses:
- BSc/BA with regulatory CMC or related experience.
- Written and verbal English communication.
Benefits (US, if applicable):
- Medical, dental, vision insurance; 401k; flexible paid vacation.
Application Instructions:
- If a current Jazz employee, apply via the Internal Career site.