Senior Manager, Global Regulatory Affairs, CMC

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.

• 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.

• 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.

• BSc/BA with regulatory CMC or related experience.
• Written and verbal English communication.

• Medical, dental, vision insurance; 401k; flexible paid vacation.