Executive Director, Regulatory Strategy

About the role

Provides strategic regulatory leadership for therapeutic area programs, overseeing all regulatory activities across the product lifecycle and collaborating with cross‑functional partners.

Key responsibilities

• Drive regulatory strategy development and execution, representing regulatory interests at enterprise‑level governance forums.
• Oversee preparation and submission of marketing authorization applications to EMA, Swissmedic, MHRA, and US agencies.
• Provide guidance on complex regulatory issues to senior management and ensure alignment with business objectives.
• Develop and maintain external relationships with regulators and industry peers.

Required profile

• BS/BA in a life science (or advanced degree) with 12‑17+ years of biopharma/regulatory experience, including leadership roles.
• Proven ability to build high‑performing teams, mentor staff, and influence across functions.
• Excellent communication skills and demonstrated diplomatic negotiation abilities.

Required skills

• Expert knowledge of regulatory environments in the US, EU (EMA, Swissmedic, MHRA) and Ex‑US CTA processes.
• Experience leading marketing application filings and post‑marketing regulatory activities.