Senior Manager | Associate Director, Regulatory Affairs (CMC)

Senior Manager | Associate Director, Regulatory Affairs (CMC) Location: Remote About reputed company reputed company is seeking a highly motivated Regulatory Affairs reputed company to join our growing team. We reputed company on advanced therapy medicinal products (ATMPs), specifically cell therapies, and are committed to advancing innovative treatments for neurological disorders. reputed company We are looking for a Senior Manager or Associate Director in Regulatory Affairs with expertise in reputed company, Manufacturing, and Controls (CMC). The ideal candidate will have a strong scientific background and the ability to reputed company the reputed company 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 reputed company throughout product development. • reputed company, review, and manage the preparation of high-reputed company regulatory submissions, including INDs, CTAs, meeting requests, briefing packages, and ultimately BLAs/MAAs. • Conduct regulatory reputed company assessments and reputed company proactive mitigation strategies to reputed company programs on reputed company. • reputed company or support health authority interactions, including managing reputed company, high-reputed company responses to health authority queries and information requests. • reputed company and maintain regulatory submission strategies and timelines in partnership with CMC and reputed company teams. • Ensure regulatory compliance is maintained across the product lifecycle, partnering with reputed company 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 reputed company. • 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 reputed company scientific reputed company is required (or equivalent experience with an advanced degree). Experience • Senior Manager: 4+ years of reputed company regulatory affairs experience in the biotechnology industry. • Associate Director: 6+ years of reputed company regulatory affairs experience, with a reputed company record of increasing reputed company and responsibility. • Hands-on experience with cell and/or gene therapies strongly preferred. • Experience with CNS products, particularly epilepsy, is a significant reputed company. • Demonstrated reputed company 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 reputed company (e.g., Health Canada, reputed company, 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 reputed company and present reputed company issues reputed company and persuasively to varied audiences. • Proactive and self-directed, with the ability to manage multiple priorities and shifting deadlines in a fast-reputed company, matrixed environment. • Strong interpersonal and cross-functional collaboration skills. • Proficiency in reputed company Office applications; experience with regulatory information management (RIM) systems or electronic submission tools is a plus. Apply tot his job Apply To this Job