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Vice President, Head of Regulatory Affairs

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

Here’s What You’ll Do:
 
  • Develop US and global regulatory strategies aligned with business objectives.
  • Provide guidance, direction, and leadership on those strategies to the development team and senior management.
  • Make strategic contributions to clinical development plans.
  • Prepare meeting requests and briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be the primary liaison with regulatory authorities for day-to-day interactions.
  • Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment.
  • Identify and collaborate with regulatory experts and consultants.
  • Coordinate and prepare responses to requests for information from regulatory authorities
  • Represent the regulatory function on cross-functional development team(s).
  • Establish, update, and implement regulatory policies, standards, and procedures for the company.
  • Ensure operations in are compliant with FDA, ICH, EMA, and industry standards.
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
  • Strengthen and lead the regulatory affairs team to support the growing pipeline
Requirements:
  • Bachelor’s degree in life sciences; advanced degree preferred
  • 15+ years' biopharmaceutical experience, including at least 5-7 years of direct experience in Regulatory Affairs
  • Track record of successful IND, CTA, NDA, and/or BLA submissions
  • Extensive knowledge of clinical development, FDA regulations, and international global clinical trial regulations
  • Knowledge of GxP regulations and ICH and FDA guidelines
  • Regulatory Affairs Certification (RAC) or education in a regulatory field preferred
  • Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents
  • Demonstrated communication, problem-solving, and negotiation/decision-making skills
  • Natural collaborator who enjoys working on a cross-functional team
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