Regulatory Affairs Director

2 days ago

Redwood City, California, United States Work In Biotech 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

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

Key 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, clinical development, and CMC.
  • Maintain detailed knowledge of global regulatory environments relevant for cell therapies and regenerative medicine, including accelerated review programs.
  • Communicate changing regulatory agency requirements and support pertinent regulatory intelligence per needs of programs.
  • Collaborate with external consultants, clinicians, and CROs to provide regulatory guidance.
  • Escalate issues to Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
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 and/or undergraduate degree in a scientific discipline is required. 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. Experience with pre and post-approval submissions and product lifecycle management is a plus.
  • Experience in biologics is preferred.
  • Ability to work in a fast-paced, start-up environment.
  • Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
What We Offer:
  • A culture inspired by our values: patients first, teamwork, scientific rigor, and curiosity.
  • A collaborative, data-driven pre-IPO start-up environment where we inspire each other to always perform at our best and focus on advancing science that will help patients.
  • Learning and development resources to help you grow professionally and potential for advancement for stronger performers.
  • Competitive compensation (Base & Performance Bonus) and stock option package (equity in an early-stage company).
  • Rich medical, dental, and vision insurance plans.
  • Health, Limited, and Dependent Care FSA; HSA with company contributions.
  • 401(k) with company matching.
  • Pre-Tax Commuter Benefits.
  • Paid Term Life and AD&D, STD, and LTD plans.
  • Employee Assistance Program (EAP).
  • Generous company-paid holidays and flexible PTO.
  • Flexible work schedule (on-site/hybrid).
  • Kitchen stocked with a variety of healthy and delicious snacks and drinks.

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