Vice President and Senior Vice President of Global Regulatory Affairs - Confidential : Job Details

Vice President and Senior Vice President of Global Regulatory Affairs

About the Company

Respected biopharmaceutical company

IndustryBiotechnology

TypePrivately Held

About the Role

The Company is in search of a Vice President/Senior Vice President of Global Regulatory Affairs to join their dedicated team. The successful candidate will be responsible for the management, development, and coordination of the regulatory affairs organization, with a focus on providing global regulatory strategy and ensuring the timely completion of regulatory activities. This leadership role requires a professional with a minimum of 15 years' experience in pharma/biotech regulatory affairs, including a strong background in global regulatory, particularly in the EU and ideally in AP. The role demands a proven track record in leading successful global 505(b)(1) launches, experience with NDA filings, and a deep understanding of regulatory processes. Experience in respiratory and rare diseases is highly valued. Applicants for this position at the company should hold a BA/BS degree, preferably in a health/life sciences or related field, and possess a strong understanding of regulatory authority guidance, including ICH. The role involves acting as the primary regulatory contact with various agencies, providing innovative regulatory approaches, and overseeing regulatory activities for product development and commercial operations. The ideal candidate will have a demonstrated ability to lead and develop regulatory teams, as well as excellent interpersonal, communication, and presentation skills. A proactive, problem-solving attitude, and the ability to work in a dynamic, cross-functional environment are essential. The company is seeking a strategic leader who can influence and inspire, and who is committed to the mission of bringing novel therapies to patients in need.

Hiring Manager TitleChief Medical Officer

Travel PercentLess than 10%

Functions

• General Management
• Operations
• Strategy