VP, Head of Regulatory

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement global regulatory strategies for both early- and late-stage development of small molecules and combination products.

• Lead and manage engagements with global regulatory agencies, including the FDA and EMA.

• Prepare, review, and submit essential regulatory documents such as INDs, CTAs, briefing books, and response packages.

• Establish and oversee a high-performing regulatory team focused on strategy, operations, and publishing.

⛳️ Requirements

• An advanced degree (PhD, PharmD, MSc, or JD) in life sciences or regulatory sciences.

• Over 15 years of experience in global regulatory affairs within the biotech/pharma sector, with a record of successful submissions.

• Proven experience in leading regulatory strategies for first-in-class or novel mechanism of action products.

• Excellent written and verbal communication skills, capable of effectively representing the company in discussions with regulators and external partners.

🏝️ Benefits

• 90% coverage for Medical, Dental, and Vision insurance.

• 401k matching program.

• Flexible Paid Time Off (PTO).

• Adoption Assistance.