Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

Even if you don’t see a job that’s a fit, but you’re excited by what Seres is doing and want to be a part of it, we’d appreciate hearing from you and will keep you in mind for a future opportunity. Click here to submit your resume. 


Senior Manager, Regulatory Operations

Department: Regulatory
Location: Cambridge, MA

Senior Manager, Regulatory Operations

We’re looking for innovators and builders at Seres.  We’ve grown a lot in the past year, but we still have a lot of infrastructure to put in place to allow even more growth.  We are flying fast towards commercialization and Regulatory Operations is a key capability that will be important for our success.  About us - we view ourselves as a pharmaceutical company as much as a biotech.   We’re small, but already have extensive manufacturing capabilities in an exciting new therapeutic space.   We have great science, but we’re also operationally savvy.   As such, we need more great colleagues that can help navigate the growing pains as we rapidly expand as leaders in the exciting space of the human microbiome.

What’s in it for you?

Quite simply, you will have an opportunity to oversee the operational aspects of regulatory submissions for a first-in-field therapeutic class that, to our knowledge, has never been approved or regulated by the FDA before. You will be a true trailblazer in our regulatory efforts to support taking bacteria from the human microbiome and developing it into a novel therapeutic to help the body heal itself and to replace the current standard of care of continued antibiotic use.  In this highly visible role, you will function as the Regulatory Operations Lead across key programs and will have the opportunity to make a significant impact in developing and implementing regulatory submission strategies.  Reporting to the Director / Executive Director / VP of Regulatory Affairs, your focus will be to ensure timely preparation, review, and delivery of high quality, compliant regulatory submissions.

How do you know if you’re the right fit?

You will enjoy it here if you embrace change and will enjoy the process of rapidly moving the company from an R&D to a GMP/Regulatory focus. You will probably have some significant small company experience in your background as well. You will also have experience in the preparation of regulatory submissions, and may even have first-hand experience in publishing regulatory submissions or coordinating with external publishing resources. If you’re looking to slightly improve a process that someone else has previously established or to manage an already existing Regulatory Operations staff, this isn’t the right place for you. If you want to develop and implement submission strategies, and establish a new operating model by leveraging your best successes and worst failures into new approaches, we’d love to talk to you.  If you’re still reading this, then that’s probably a good sign.  Send us your resume.  

The other stuff

This role is typically best suited for Life Sciences Bachelor’s level candidates with a minimum of 5-8 years of pharmaceutical industry experience in a submission focused Regulatory Operations function.  To be successful, you will have hands-on experience in the preparation, management, and delivery of submissions to the FDA and other regulatory agencies. 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. Knowledge of FDA and ICH regulations and guidelines, as well as standard industry practice pertaining to regulatory submissions goes with the territory.  If you are RAC certified, it’s a plus.

 

 

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