Senior Manager / Associate Director, Regulatory AffairsThis role spans both Clinical and CMC (Chemistry, Manufacturing, and Controls) regulatory affairs, and the ideal candidate brings a strong scientific background along with the ability to navigate the complex regulatory landscape for advanced therapy medicinal products (ATMPs) - specifically cell therapies. This position reports to the Head of Regulatory Affairs and plays a critical role in advancing our clinical programs toward market approval.
Key Responsibilities:- Serve as a regulatory strategist and subject matter expert, advising clinical, CMC, and technical teams on regulatory requirements and pathways throughout development
- Author, review, and manage the preparation of high-quality regulatory submissions, including INDs, CTAs, meeting requests, briefing packages, and ultimately BLAs/MAAs
- Conduct regulatory risk assessments and develop proactive mitigation strategies to keep programs on track
- Lead or support health authority interactions, including managing timely, high-quality responses to health authority queries and information requests
- Develop and maintain regulatory submission strategies and timelines in partnership with Clinical, CMC, Quality, and Nonclinical teams
- Ensure regulatory compliance is maintained across the product lifecycle, partnering with internal and external stakeholders (e.g., CROs, CDMOs, regulatory consultants)
- Monitor and interpret evolving regulatory guidance and precedent relevant to cell therapies, with particular attention to the epilepsy and broader CNS space
- Contribute to the development of departmental processes, templates, and best practices as the regulatory function scales
- Mentor and, over time, manage junior regulatory staff as the department grows
Education:- PhD in Neuroscience, Cell Biology, Biochemistry, or a related scientific field is required (or equivalent experience with an advanced degree)
Experience:- Senior Manager: 4+ years of direct regulatory affairs experience in the biotechnology industry
- Associate Director: 6+ years of direct regulatory affairs experience, with a track record of increasing scope and responsibility
- Hands-on experience with cell and/or gene therapies strongly preferred
- Experience with CNS products, particularly epilepsy, is a significant advantage
- Demonstrated success authoring and submitting major regulatory filings (e.g., IND, CTA, BLA, MAA) and leading or supporting health authority interactions
Knowledge and Skills:- Deep understanding of US FDA (CBER) and EU EMA regulatory requirements, guidelines, and processes; experience with other regions (e.g., Health Canada, MHRA, PMDA) is a plus
- Strong working knowledge of GMP, GCP, and GLP regulations
- Excellent scientific writing, editing, and verbal communication skills, with the ability to distill and present complex issues clearly and persuasively to varied audiences
- Proactive and self-directed, with the ability to manage multiple priorities and shifting deadlines in a fast-paced, matrixed environment
- Strong interpersonal and cross-functional collaboration skills
- Proficiency in Microsoft Office applications; experience with regulatory information management (RIM) systems or electronic submission tools a plus
