Vice President, Global Regulatory Affairs

Vice President, Global Regulatory Affairs

About the Company

Respected biotechnology (BioTech) company

Industry

Biotechnology

Type

Privately Held

About the Role

The Company is in search of a Vice President / Senior Vice President for Global Regulatory Affairs. The successful candidate will be responsible for leading the global regulatory strategy for assigned products, ensuring that all plans meet the necessary regulatory requirements. This role involves the development, strategizing, and submission of various regulatory documents, as well as leading and preparing for health authority meetings. The VP / SVP will also be tasked with identifying and assessing regulatory risks, providing technical guidance to internal stakeholders, and staying abreast of evolving global regulatory requirements. A key aspect of the position is to mentor and develop a high-performing regulatory affairs team and to act as the primary point of contact with global health authorities.

Applicants must have an advanced degree in a relevant scientific discipline and a minimum of 15 years of industry experience, with at least 10 years in a leadership role within regulatory affairs in the biotech or pharma sector. Expertise in US FDA regulations and global health authority policies is essential, as is a proven track record of successful NDA submissions and approvals. The role requires exceptional leadership, communication, negotiation, and stakeholder engagement skills. The ideal candidate will be a strategic leader with a deep understanding of regulatory affairs, capable of thriving in a collaborative, mission-driven environment at the forefront of biotech innovation.

Travel Percent

Less than 10%

Functions

• Finance
• Legal