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Associate Director, Regulatory Affairs

Seaport Therapeutics · Boston, MA · On-site

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About Seaport Therapeutics

Backed by Third Rock Ventures.

About the role

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor’s degree required, advanced degree in a scientific discipline preferred
  • 7+ years in global regulatory affairs, including expertise in early development (Pre-IND/IND) and late-phase strategy for CNS therapies
  • Relevant hands-on experience leading IND/CTA and/or NDA/MAA submissions
  • Leading Pre-IND or INTERACT meetings and IND/CTA submissions for psychiatry/neurology programs
  • Designing Phase II PoC studies with validated endpoints
More about this role

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com .

The Role

We are seeking a strategic, hands-on Associate Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned development programs. We seek a candidate who thinks innovatively and has deep expertise in early development (Pre-IND/IND) and Phase II proof-of-concept (PoC) strategy, coupled with...

Read the full posting on Seaport Therapeutics's site ↗

Regulatory

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