Director, CMC Regulatory Affairs

Department: Regulatory
Location: Cambridge, MA
Director, CMC Regulatory Affairs
Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases, and are designing live bacterial ecologies to act as therapeutics. We are currently conducting multiple clinical trials including a recently started Phase III study.  Seres is a dynamic and well-financed biotechnology company headquartered in Cambridge, MA.

What’s in it for you?
This is a great opportunity for you if you have strong knowledge of the biologics development 
and regulatory processes and you enjoy being in a highly visible and influential role leading the CMC regulatory function.  In this leadership position, you will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filings for a novel class of live bacterial Ecobiotic® therapies to treat infectious diseases, inflammatory bowel disease, and other disease areas such as immuno-oncology and metabolic disease.    

How do you know if you’re the right fit?
This is a great opportunity for you if you are looking to directly impact the success of Seres through the preparation of International regulatory submissions (CMC sections of INDs/CTAs and BLAs/MAAs, and regulatory briefing documents).  Your ability to partner closely with the Head of Regulatory Affairs and the Chief Technology Officer to provide strategic guidance and support on regulatory expectations and messaging has often been seen as your best asset.  You like to spend much of your time collaborating with scientists and engineers to support the development of the CMC sections of BLAs
/MAAs, INDs/CTAs, and Investigator Brochures for new products.  You know the importance of accurately preparing all documents in support of CMC programs including publications, abstracts, statistical and safety analyses, and reviews of literature. And you are comfortable reviewing and interpreting clinical and scientific data.

The technical requirements?
Ideally, we are searching for a CMC professional who holds a Ph.D. or a Master’s degree with exceptional experience preferably with biologics.  And, we’d love to see a few non-confidential examples of your strong writing skills.

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