Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

Small, scientifically-driven team 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 health authorities, and driving submissions for various 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 in a relevant field, and at least 12 years of experience in regulatory affairs within the pharmaceutical or biotech industry. Applicants for the Head of Regulatory Affairs role at the company should have a proven track record of direct ownership of regulatory submissions, particularly NDAs and BLAs, and a strong history of interaction with the FDA. Experience with orphan drug designations is a plus. The role demands a candidate who is comfortable operating as the scientific and regulatory authority internally, and who is adept at building in a lean environment. The position is not suited to those who have moved into pure process management, but rather to individuals who have remained close to the scientific aspects of the field. The Head of Regulatory Affairs will be expected to work closely with senior leadership and be a key player in the expansion of the company's pipeline into additional indications.

Functions

• Operations