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Associate Director CMC Regulatory Affairs, Cambridge
Client:
Location: Cambridge, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 924d4659edab
Job Views: 9
Posted: 14.07.2025
Expiry Date: 28.08.2025
Job Description:
Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory filings for cellular & gene therapy projects (CAR T cell therapy) both in the US and internationally for our growing oncology franchise. In this position, you will be responsible for developing innovative CMC regulatory strategies and preparing high‑quality CMC sections of INDs, CTAs, and marketing applications (BLAs/MAAs), in collaboration with our CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, and global health authorities.
In this role, a typical day might include:
* Overseeing the preparation and review of CMC regulatory submissions and managing interactions with regulatory health authorities.
* Developing global CMC regulatory science strategies for internal and external oncology investigational products.
* Communicating regulatory strategies, risks, and plans to leadership and stakeholders.
* Partnering with cross-functional CMC teams, including Development, Manufacturing, Supply, Quality, Regulatory Project Management, and external teams.
* Ensuring compliance with relevant CMC regulatory guidelines.
* Assessing manufacturing changes and providing regulatory guidance.
* Monitoring regulatory guidelines and providing interpretative guidance to CMC teams.
This role might be for you if you have:
* A proven track record supporting cell and gene therapy products through development and approval.
* Some antibody experience is a plus.
* Experience in expedited development and approval pathways.
* Strong organizational and communication skills.
* Ability to manage technical SMEs and align teams towards goals.
* Comprehensive knowledge of FDA, EMA, and ICH guidelines.
To be considered for this opportunity you must have:
* A minimum of BS in life sciences, biochemistry, biology, or related fields; Masters or PhD preferred.
* At least 8+ years in the pharmaceutical or biotech industry, with 5+ years in Regulatory Science CMC for biologics, and 3+ years in Cell & Gene Therapy products.
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