Regulatory Affairs Director

4 weeks ago


Redwood City, California, United States Biomea Fusion, Inc. Full time
Job Title: Associate Director, Regulatory Affairs

Biomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.

Key Responsibilities:
  • Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology projects.
  • Collaborate with internal staff to author and support submissions to achieve successful approvals of clinical trials and marketing applications.
  • Manage timelines and expectations to ensure a positive experience.
  • Act as SME with deep knowledge of regulations for all aspects of pharmaceutical development.
  • Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
Requirements:
  • Bachelor's or master's degree in a scientific field.
  • At least 8 years of progressive regulatory experience in Regulatory Affairs for pharmaceutical and/or biotechnology company.
  • Experience with Phase 1 through Phase III products and/or marketing applications is highly desirable.
  • Demonstrated experience supporting regulatory writing and electronic submission.
  • Proven direct experience interacting with the FDA and other health authorities is highly desired.
What We Offer:

Biomea Fusion, Inc. offers a competitive salary range of $170,000 to $190,000, a comprehensive benefits program, and opportunities for professional growth and development.

We are an equal opportunity employer and welcome applications from diverse candidates.



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