Job Description
MEET have partnered with one of our cutting-edge biotech clients focused in the cell-therapy space to bring on a Senior Director of Regulatory Affairs to their wonderful team.
Responsibilities:
- Lead the Regulatory Affairs team in managing global clinical regulatory activities, including strategy development, regulatory submissions (IND/CTA, NDA/BLA/MAA), and health authority interactions across all development phases.
- Provide cross-functional regulatory leadership for pivotal and registrational studies, ensuring alignment with global regulatory requirements and contributing to study design, protocols, ICFs, SAPs, and CSRs.
- Serve as the primary regulatory contact with health authorities, directing the preparation of meeting materials, responses to inquiries, and ex-US filings to support clinical development and marketing authorizations.
- Develop and implement departmental strategies, policies, SOPs, and risk management approaches to ensure regulatory compliance and operational excellence.
- Oversee regulatory input for due diligence, partnering, product integrations, and cross-functional collaboration with clinical development, operations, quality, and safety teams.
- Mentor and manage Regulatory Affairs staff, fostering a high-performing team culture through clear goal setting, performance oversight, delegation, and open communication.
Knowledge & Experience:
- Hold a BS/MS/PhD in life sciences with 12+ years of progressive Regulatory Affairs experience in the biotech or pharmaceutical industry, including leadership of regulatory teams and pivotal/registrational study support.
- Demonstrate expertise in Health Authority submissions and strong working knowledge of FDA, EMA, MHRA regulations, clinical development pathways, and GCP principles, with direct experience in CTA filings and prior HA interactions.
- Possess deep understanding of clinical regulatory documentation (protocols, ICFs, CSRs), and cross-functional clinical areas such as clinical operations, safety, and clinical development.
- Exhibit strong operational, communication, and writing skills with a high attention to detail; adept at managing multiple projects under tight deadlines while working independently.
- Highly adaptable with the ability to absorb complex technical information quickly; cell therapy product experience and regulatory knowledge are highly preferred, with GCP inspection participation considered a plus.
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