Junto HLS has been engaged by Sr. Leadership at a growing, mid-cap pharma to recruit an Associate Director, Global Regulatory Affairs CMC Biologics.
- Responsible for managing and leading registration and CMC regulatory support for commercial and development projects worldwide.
- Planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items.
- Participate as an active member of a multi-disciplinary team to establish development of Regulatory CMC strategies for commercial products, late, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
- Manage EU, US, International commercial license maintenance.
- Provide in-depth reviews of protocols, reports, presentations, and documents.
- Manage CMC related regulatory agency interactions.
- Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
- Act as primary regulatory CMC representative at internal meetings as well as support at meetings with business partners and regulatory agencies for CMC related issues.
- Monitor Global CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
- Ensure continued regulatory compliance of products though change control procedure.
- Participate in the quality verification of regulatory submissions.
- Provide risk assessments and recommendations for various regulatory scenarios.
- Philadelphia, PA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.