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Regulatory Affairs Director
1 month ago
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 AffairsThe 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 environment 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
- 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
Nuvig Therapeutics, Inc., headquartered in Redwood City, California, is a science-driven research and clinical development organization focused on fundamentally 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. 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. Key investors include Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital.
