Vice President – Regulatory Affairs

Job Title: Global Vice President of Regulatory Affairs

Location: United States (Flexible/Remote)

Reports to: Chief Medical Officer (CMO)

Department: Regulatory Affairs

Position Type: Full-Time, Executive Level

Scienta Search is seeking a seasoned and strategic leader to join our executive team as the Global Vice President of Regulatory Affairs. This position will be responsible for developing and executing global regulatory strategies to ensure the successful registration, approval, and commercialization of our innovative biotech products

Global Regulatory Submissions:

• Oversee the preparation, submission, and management of regulatory applications including INDs, NDAs, BLAs, MAAs, and other relevant filings across multiple regions (FDA, EMA, PMDA, etc.).
• Build, lead, and mentor a high-performing global regulatory affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
• Manage interactions with regulatory agencies, including negotiations and meetings to facilitate product approvals.
• Align regulatory strategies with the company’s business goals and pipeline priorities.

Requirements:

• Minimum of 15 years of experience in regulatory affairs within the biotech or pharmaceutical industry, with at least 8 years in a senior leadership role.
• Solid background working on Biotech products eg Biologics or Small molecules
• Proven track record of successful regulatory submissions and approvals in the U.S., Europe, and other major markets.
• Extensive experience interacting with regulatory agencies (FDA, EMA, etc.) and navigating complex regulatory environments.