Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Senior Director, Regulatory Affairs

Department: Regulatory
Location: Cambridge, MA

Senior Director, 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.

Whatís in it for you?
Seres Therapeutics is currently expanding its Regulatory team to support its developmental and clinical assets. This individual will operate in a high visibility role and will be responsible for representing Regulatory Affairs on the Global Teams for one or more key assets, developing regulatory strategies and managing high-quality submissions to regulatory agencies.  As Seres develops clinical assets there could be additional duties and responsibilities to this role, including the expansion and management of additional team members.  This position reports to the Vice President, Regulatory Affairs

How do you know if youíre the right fit?
This is a great opportunity for you if you are looking to directly impact the success of Seres through the proposal and design well-informed regulatory strategies for the US, EU and other countries as needed. You will represent Regulatory Affairs on designated Global Project teams and project sub teams, especially Clinical and Nonclinical, and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans). This individual will also assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS), lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages, and write regulatory documents to support regulatory submissions. Additional responsibilities will include coordinating with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies, establishing relevant processes and procedures to support the Regulatory Affairs function activities, participating in regulatory intelligence gathering activities, and maintain knowledge of US and EU regulatory requirements.

The technical requirements?
Ideally, we are searching for a Regulatory Affairs professional who holds a Ph.D. or a Masterís degree and has 10+ years pharmaceutical industry experience with a minimum of 8 years in Regulatory Affairs. You should have evidence of successful submissions to FDA (e.g., INDs, briefing packages) and demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans). Knowledge of FDA and ICH regulations and guidelines a must and knowledge of EU and Health Canada regulations and guidelines highly desirable.  

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