Head of Regulatory Affairs

About the Company

Promising biotechnology company

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is in search of a Head of Regulatory Affairs with a focus on oncology and radiopharmaceuticals. The successful candidate will be responsible for leading the development and implementation of global regulatory strategies, from IND through BLA submissions. This pivotal role involves overseeing all regulatory submissions and serving as the primary contact for FDA, EMA, and other global agencies. The Head of Regulatory Affairs will also be tasked with collaborating with cross-functional teams, including clinical, CMC, and pharmacovigilance, to ensure compliance and timely filings. Additionally, the role includes representing the company at regulatory meetings, advising on risk assessment and strategy, and monitoring emerging trends to maintain a leading position in regulatory science.
Applicants for the Head of Regulatory Affairs position at the company should have a minimum of 15 years’ experience in biotech or pharma, with at least 10 years specifically in regulatory affairs. Expertise in oncology solid tumor and biologics regulatory pathways is essential, and experience with development programs of radioligand treatments is required. The ideal candidate will have a proven track record of successful IND, NDA, and BLA submissions, with experience in radioligand programs being a strong plus. An advanced degree (MS, PhD, MD) in life sciences or a related field is also necessary. The role offers the opportunity to lead impactful oncology programs in a collaborative, mission-driven environment and to engage with senior leadership and regulatory agencies on pivotal filings.

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration