Global Regulatory Project Lead (m/f/d)

Global Regulatory Project Lead (m/f/d)

As Global Regulatory Project Lead, you will lead regulatory strategy for global innovation projects across pre‑approval and development‑driven life cycle management, with direct accountability for the European Union (EU) and United States (USA) regulatory approach and processes.

In this role, you will partner with research and development, sales and marketing, supply chain, manufacturing, quality, finance, legal, and technical services teams to align regulatory plans, manage risk, and support first‑wave registrations in key countries.

Your Responsibilities

• Lead global regulatory strategy, submission planning, and technical dossier development for biologics or other large molecule innovation projects, with direct ownership for EU and USA regulatory activities.
• Drive pre‑approval and development‑driven life cycle management activities, including clinical trial submission plans and Quality, Sa...