Senior Manager / Associate Director, Regulatory Affairs

About the Role

Neurona Therapeutics is seeking a highly motivated Regulatory Affairs professional to join our growing team. This role spans both Clinical and CMC (Chemistry, Manufacturing, and Controls) regulatory affairs, focusing on advanced therapy medicinal products (ATMPs), specifically cell therapies. The position reports to the Head of Regulatory Affairs and plays a critical role in advancing our clinical programs toward market approval.

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.

Requirements

• PhD in Neuroscience, Cell Biology, Biochemistry, or a related scientific field is required (or equivalent experience with an advanced degree).
• 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.

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.