Senior Manager | Associate Director, Regulatory Affairs (CMC)

Location: Remote

About Neurona Therapeutics

Neurona Therapeutics is seeking a highly motivated Regulatory Affairs professional to join our growing team. We focus on advanced therapy medicinal products (ATMPs), specifically cell therapies, and are committed to advancing innovative treatments for neurological disorders.

Position Overview

We are looking for a Senior Manager or Associate Director in Regulatory Affairs with expertise in Chemistry, Manufacturing, and Controls (CMC). The ideal candidate will have a strong scientific background and the ability to navigate the complex regulatory landscape for cell therapies. Reporting to the Head of Regulatory Affairs, this role is critical in advancing our programs toward market approval.

Key Responsibilities

• Serve as a regulatory strategist and subject matter expert for CMC and technical teams on regulatory requirements and pathways throughout product 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 CMC and Quality teams.
• Ensure regulatory compliance is maintained across the product lifecycle, partnering with internal and external stakeholders such as CROs, CDMOs, and regulatory consultants.
• Monitor and interpret evolving regulatory guidance and precedent relevant to cell therapies, with particular attention to epilepsy and the 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 is a plus.