Regulatory Affairs Director

4 hours ago

Redwood City, California, United States Work In Biotech Full time
Transformative Opportunity in Regulatory Affairs

Nuvig Therapeutics is seeking a highly experienced Director, Regulatory Affairs to join our dynamic team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies to support our investigational studies. This is an exciting opportunity to play a critical role in shaping the future of our company and advancing innovative therapies for patients with autoimmune diseases.

Key Responsibilities
  • Lead program teams in preparing regulatory submissions, including briefing documents and IND/CTA filings
  • Oversee preparation of responses to regulatory authority queries
  • Manage critical clinical regulatory timelines and collaborate with team members to resolve issues related to non-clinical studies and clinical development
  • Maintain detailed knowledge of global regulatory environments relevant to cell therapies and regenerative medicine
  • Communicate changing regulatory agency requirements and provide regulatory intelligence to support program needs
  • Collaborate with external consultants, clinicians, and CROs to provide regulatory guidance
  • Escalate issues to management that affect registration, regulatory compliance, and product lifecycle management

Requirements
  • Strong knowledge of eCTD elements and structure, as well as regulatory writing skills
  • Demonstrated knowledge of regulatory requirements in clinical trial design and conduct, including preparation of regulatory submissions
  • Experience with Orphan Drug Designation and BTD is preferred
  • Effective written and oral communication skills
  • A minimum of a Bachelor's degree in a scientific discipline, with an advanced degree preferred
  • 10+ years of biopharmaceutical industry experience, with at least 8 years in regulatory affairs
  • Knowledge of FDA and EU regulations is required, with experience in filing regulatory submissions from early development 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 product lifecycle management is highly preferred

What We Offer
  • A collaborative, data-driven pre-IPO start-up environment where we inspire each other to 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

About Nuvig
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 engineered to target immunomodulatory Type 2 Fc receptors and modulate immune response. Additional efforts are focused on engineering full-length therapeutic antibodies to maximize their ability to control aggressive autoimmune diseases. Founded in 2021 by industry experts, Nuvig Therapeutics is well-supported by top-tier investors, ensuring robust funding to drive our innovative research and clinical programs forward.

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