Sr. Manager, Regulatory Affairs
6 days ago
Position Summary:
Neurona is seeking a highly motivated Regulatory Affairs professional to join our growing team. This role will focus on both Clinical and CMC (Chemistry, Manufacturing, and Controls) aspects of Regulatory Affairs. The ideal candidate will have a strong scientific background, capable of navigating the complex regulatory landscape for advanced therapy medicinal products (ATMPs). The role will report to the head of Regulatory Affairs department and play a critical role in advancing our clinical programs towards market approval.
Key Responsibilities:
- Provide guidance to technical and clinical teams
- Conduct rigorous regulatory risk assessment and propose proactive mitigation strategies
- Author, review, and manage the preparation of high-quality regulatory documents for submission, including INDs, CTAs, meeting requests, briefing packages, and ultimately BLAs/MAAs
- Manage and oversee the timely response to health authority queries
- Interface with internal and external teams to ensure regulatory compliance throughout the product lifecycle
- Collaborate effectively with internal teams
- Stay abreast of regulatory precedents and guidance related to cell therapies in the field of drug-resistant epilepsy
- Mentor and potentially manage junior regulatory staff as the department grows
Qualification and Experience:
Education:
- PhD in Neuroscience, Cell Biology, Biochemistry, or a related field is required
Experience:
- Manager; 3+ years of direct regulatory affairs experience in the biotechnology industry
- Director: 6+ years of direct regulatory affairs experience, with a proven track record of increasing responsibility in the biotechnology industry
- Direct hands-on experience with cell and/or gene therapies is highly preferred
- Experience with CNS products, particularly in epilepsy is a significant advantage
- Proven success in authoring and submitting major regulatory filings (eg IND, CTA ,BLA, MAA) and leading health authority interactions
Knowledge and Skills:
- Deep understanding of US FDA (CBER) and EU EMA regulatory requirements, guidelines, and processes. Experience with other regions (eg Canada, UK, Japan) is a plus
- Strong knowledge of GMP, GCP, and GLP regulations
- Excellent problem-solving, scientific writing, editing, and verbal communication skills, with the ability to present complex issues clearly and persuasively
- Proactive, able to follow directions, work independently, multitask, and prioritize workload in a fast-paced dynamic, matrix environment
- Profieciency in Microsoft Office applications
What We Offer:
- The chance to work on a transformative therapy that has the potential to change the standard of care for patients with drug-resistant epilepsy
- A collaborative and innovative work environment with a focus on professional development
- A competitive compensation and benefits package, including equity
- This hybrid role offers flexibility, with three days onsite each week for collaboration and connection.
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