Director, Regulatory Affairs Strategy - Oncology
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About The Position
The Director of Regulatory Affairs will play a pivotal role in leading global regulatory activities for oncology products at Regeneron Pharmaceuticals. This position is primarily focused on Clinical Regulatory filings, providing essential regulatory leadership to project teams involved in these activities. The culture at Regeneron is hands-on, which means that the Director will also be involved in supporting various clinical study activities. The responsibilities include leading and supervising the preparation of Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and Biologics License Applications (BLA). A typical day in this role may involve interpreting feedback from regulatory authorities, developing regulatory strategic plans in collaboration with project teams, and ensuring the quality and timeliness of submissions. The Director will work closely with project teams to address complex project issues, utilizing their regulatory expertise to interpret and communicate requirements effectively. This role requires a strong understanding of US FDA regulations and international pharmaceutical guidance, as well as the ability to manage interactions with Contract Research Organizations (CROs) for clinical trial activations outside the US and EU. The ideal candidate will possess excellent leadership, negotiation, and project management skills, demonstrated through past performance in drug development project teams. Strong interpersonal skills, both written and verbal, are essential, as is a high attention to detail and the ability to prioritize projects according to company goals. The position requires a Doctoral degree (MD, Ph.D., or Pharm D.) and a minimum of 10 years of experience in the pharmaceutical industry, with at least 7 years in regulatory affairs. This role mandates onsite work three days a week in Basking Ridge, NJ, Armonk, NY, or Tarrytown, NY.
