Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Executive Director, Regulatory Affairs

Department: Regulatory
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course.  You’ll have the opportunity to truly define your area of focus.

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

Seres is currently expanding its Regulatory team to support our growing and advancing pipeline.  As Executive Director, reporting directly to our SVP of regulatory Affairs, you will operate in a high visibility role and will be responsible for representing Regulatory Affairs on the Global Teams for several key assets, developing regulatory strategies and managing high-quality submissions to regulatory agencies.  As a pioneer in the Microbiome space, you will have the opportunity to bring, first in class, drugs to market.   

What You’ll Do

  • 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)
  • 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

What You’ll Bring

  • holds a Ph.D. or a Master’s degree and has 10+ years pharmaceutical industry experience
  • minimum of 8 years in Regulatory Affairs.
  • 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)

You May Also Bring

  • Knowledge of FDA and ICH regulations and guidelines a must and knowledge of EU and Health Canada regulations and guidelines highly desirable. 

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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