Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs will serve as a Global Regulatory Lead for oncology radiopharmaceutical programs. The role drives clinical and nonclinical regulatory strategy, authors regulatory documents, leads regulatory filings, and manages interactions with regulators such as FDA and EMA.

• Serve as Global Regulatory Lead for oncology RPT programs
• Develop clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
• Author regulatory documents required for regulatory interactions
• Lead preparation and submission of regulatory filings (IND, IND amendments, CTA/IMPD, iPSP/PIP, safety reports, marketing applications)
• Lead regulatory authority interactions including FDA teleconferences and EMA scientific advice

This is a global regulatory affairs leadership position covering therapeutic and diagnostic (imaging) radiopharmaceutical products. The scope includes preparation and submission of IND, IND amendments, CTA/IMPD, iPSP/PIP, safety reports, annual reports, and marketing applications, plus authority interactions (FDA teleconferences and EMA scientific advice) grounded in radioisotope knowledge (e.g., 68Ga, 177Lu, 225Ac).

The ideal candidate is an experienced regulatory professional with 7+ years of hands-on regulatory experience, serving as a Global Regulatory Lead (GRL) for oncology radiopharmaceutical programs. They have authored regulatory documents, led IND/CTA/IMPD and safety/marketing submissions, and coordinated regulatory authority interactions including FDA teleconferences and EMA scientific advice with radiopharmaceutical familiarity (e.g., 68Ga, 177Lu, 225Ac).