Head Of Regulatory Affairs

Head of Regulatory Affairs About the Company Innovative biotechnology (BioTech) portfolio

Industry
Biotechnology

Type
Privately Held








About the Role The Company is in search of a Head of Regulatory Affairs to take on a pivotal role in leading strategic regulatory decisions for its innovative biotech portfolio. The successful candidate will be a core member of the leadership team, responsible for guiding global regulatory pathways, ensuring compliance with FDA and global regulations, and managing IND/BLA submissions. This hands-on leadership position requires a professional with over 10 years of experience in regulatory affairs within a biotech or pharma environment, with a specific focus on oncology and immuno-oncology. The role also involves overseeing and mentoring a growing regulatory team and demands a leader who can bring both tactical execution and strategic insight to the dynamic and cutting-edge nature of the portfolio.

Applicants for the Head of Regulatory Affairs position at the company must have a strong background in regulatory affairs, particularly in the context of oncology and immuno-oncology. A deep understanding of FDA and global regulations is essential, and experience with IND/BLA submissions is advantageous. The role is suited to a dynamic and collaborative individual who can excel in a fast-paced environment and is capable of making high-level strategic decisions. The Head of Regulatory Affairs will work closely with the C-suite, making it imperative that the candidate is a proven leader with the ability to manage a team and drive the regulatory strategy of the organization.




Travel Percent
Less than 10%

Functions Medical Care/Hospital Administration