Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Senior Manager, 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?

You will act as the regulatory lead on designated clinical projects, contributing to the development and implementation of regulatory strategy, provide regulatory guidance, and serving as the regulatory contact with relevant regulatory authorities, including managing queries, meeting requests, responses, as appropriate.  You will also be responsible for the maintenance and support of regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of regulatory information.

What You’ll Do

  • Act as regulatory strategy lead for US, Canada and EU regulatory submissions (INDs, IMPD/CTAs and NDA/MAAs) including creating and maintaining regulatory trackers and timelines, management updates, scheduling team meetings, creating agenda, meeting minutes and conducting follow-up on action items with team members.
  • Contribute to the development and implementation of clinical, pre-clinical and cmc regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Assist in compiling regulatory submissions for all assigned projects. Coordinate distribution of submissions to all concerned parties e.g. health authorities, CRO’s, development and commercialization partners, within agreed upon timeframes
  • Be responsible for all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing (non-outsourced projects), production (paper and electronic), and archiving (paper and electronic)
  • Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products

What You’ll Bring

  • A Bachelor’s degree with a minimum 8 years pharmaceutical industry experience, 5 of which are focused on regulatory submissions
  • Hands-on experience in the preparation, writing, management, and delivery of submissions to the FDA and other regulatory agencies
  • A demonstrated ability to work in cross functional teams and lead without authority
  • You will also have effective communication and project management skills, as well as demonstrated working knowledge of information systems and technology used for the preparation and review of regulatory submissions such as eCTD, EDMS and related publishing tools

You May Also Bring

  • RAC certification is a plus

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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