Director of Regulatory Affairs

1 day ago

Redwood City, California, United States Nuvig Therapeutics Inc. Full time
Transformative Therapies for Autoimmune Diseases

Nuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.

Director, Regulatory Affairs

This key role will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical, and CMC disciplines in support of investigational studies. The Director, Regulatory Affairs will be a key member of project teams and reports to the Head of Regulatory Affairs.

Responsibilities
  • Lead program teams in preparing regulatory submissions, including briefing documents and IND/CTA filings
  • Oversee preparation of responses to all regulatory authority queries
  • Manage critical clinical regulatory timelines and work with team members to resolve issues related to non-clinical studies, and clinical development
  • Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine, including accelerated review programs
  • Collaborate with external consultants, clinicians, and CROs to provide regulatory guidance
Requirements
  • Strong knowledge of eCTD elements and structure, and regulatory writing skills
  • Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
  • Experience with Orphan Drug Designation and BTD is preferred
  • Effective and efficient written and oral communication skills
  • A minimum of a Bachelor's degree in a scientific discipline is required; an advanced degree is a plus
  • 10+ years of biopharmaceutical industry experience, with at least 8 years in regulatory affairs
  • Knowledge of FDA and EU regulations is required; experience in filing regulatory submissions from early development is a must
About Nuvig Therapeutics

Nuvig Therapeutics, Inc. is a science-driven research and clinical development organization focused on transforming how we approach and treat inflammatory and autoimmune diseases. Our first product candidate NVG-2089 is a recombinant, human IgG1 Fc fragment that has been engineered to target immunomodulatory Type 2 Fc receptors and modulate immune response.

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