Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

A small, scientifically-driven company advancing a novel mechanism for rare disease treatments.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is seeking a Head of Regulatory Affairs to take on a senior role within a small, scientifically-driven team. The successful candidate will be responsible for owning the global regulatory strategy across development and post-approval programs, leading direct engagement with FDA, EMA, and other health authorities, and driving submissions for NDAs, BLAs, and Orphan Drug Designations. This is a hands-on position that requires the ability to not only oversee submissions but also to write, defend, and own them. The ideal candidate will have a background in science, with an advanced degree (PharmD, PhD, or MD), and at least 12 years of experience in regulatory affairs within the pharma or biotech industry. Applicants for the Head of Regulatory Affairs role at the company should have a proven track record of direct ownership of an NDA or BLA submission, with a strong history of interaction with the FDA. Experience in orphan drug designations is a plus. The role demands a candidate who is comfortable operating as the scientific and regulatory authority internally and is adept at building in a lean environment. The position is not suited for those who have moved into pure process management; the focus is on a candidate who has remained close to the scientific aspects of the field. The Head of Regulatory Affairs will work closely with senior leadership and must be prepared to be hands-on in their approach.

Functions

• Product Management