Vice President/Senior Vice President of Regulatory Affairs - Confidential : Job Details

Vice President/Senior Vice President of Regulatory Affairs

About the Company

A respected biopharmaceutical company committed to innovation.

Industry Biotechnology

Type Privately Held

About the Role

We are looking for a dynamic Vice President or Senior Vice President of Regulatory Affairs to join our dedicated team at our biopharmaceutical company. This pivotal role involves leading the regulatory affairs organization by driving the global regulatory strategy and ensuring the timely execution of all regulatory activities. The ideal candidate will possess a minimum of 15 years of experience in the pharmaceutical or biotechnology field, with a deep expertise in global regulatory matters, particularly within the EU and preferably in the Asia-Pacific region.

You should have a proven track record in successfully leading global 505(b)(1) product launches, along with significant experience in NDA filings and a thorough understanding of regulatory processes. Experience in respiratory and rare diseases will be a strong advantage. A Bachelor's degree in health/life sciences or a related field is required, along with a solid grasp of regulatory authority guidance, including ICH standards.

In this role, you will serve as the principal regulatory contact for various agencies, bringing innovative regulatory strategies to the table while overseeing regulatory activities across product development and commercial operations. We seek a strategic leader with a demonstrated ability to build and mentor high-performing regulatory teams, along with strong interpersonal, communication, and presentation skills. A proactive and solution-oriented mindset, coupled with the agility to thrive in a fast-paced, cross-functional environment, is essential.

If you are passionate about driving the mission to deliver groundbreaking therapies to those in need and ready to influence and inspire others in the field, we would love to hear from you.

Hiring Manager Title Chief Medical Officer

Travel Percent Less than 10%

Functions

• General Management
• Operations
• Strategy