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Regulatory Affairs Director

2 months 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

We are seeking a highly experienced Director, Regulatory Affairs to join our team. As a key member of our project teams, you will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical, and CMC disciplines in support of investigational studies.

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 environment relevant for cell therapies and regenerative medicine, including accelerated review 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 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
  • 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
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

The salary range for this position is $230,000 to $260,000. Nuvig considers various factors when determining the base compensation, including market survey data, experience, qualifications, and geographic location, which means that the actual compensation will vary.