Senior Vice President & Global Head Of Regulatory Affairs

Senior Vice President & Global Head of Regulatory Affairs About the Company Diverse biotechnology company

Industry
Biotechnology

Type
Privately Held








About the Role The Company is seeking a Senior Vice President/Global Head of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the development and implementation of global regulatory strategies, with a primary focus on the US and EU. This role involves managing all activities related to the regulatory submissions process, including serving as the primary contact for the FDA and other Health Authorities. The SVP / Global Head of Regulatory Affairs will also be accountable for the strategic direction, leadership, and operational success of the regulatory department, and must have a proven track record of success in regulatory affairs, particularly in the field of oncology.

Applicants must have an advanced degree (Ph.D., Pharm.D., MD, MS, or JD) and at least 20 years' experience in regulatory affairs, with a minimum of 10 years specifically in oncology. A strong background in leading regulatory strategy and execution for global Phase II studies is essential. The role requires a candidate with at least 5 years' experience in people management and a track record of significant accomplishments in regulatory affairs, including success in filing BLA. The successful candidate will also be responsible for building and managing both internal and external regulatory affairs teams, and ensuring that the company's regulatory structure and resources align with its goals and objectives.

Hiring Manager Title
Chief Medical Officer



Travel Percent
Less than 10%

Functions Medical Care/Hospital AdministrationStrategy