Associate Director, Global Regulatory Strategy

Associate Director, Global Regulatory Strategy

Eisai

Hatfield, United Kingdom

Your new role

The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for products within the Neurology portfolio (development and post-approval). The Associate Director will hold either an EU Regulatory Lead role or Global Regulatory Lead role (or both) depending on the portfolio of products assigned. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.

What are we looking for?

• BS/BA degree in Life Sciences in a relevant field with extensive demonstration of broad pharmaceutical experience, including new drug regulated product; strategy/submissions; or a Master's or PharmD/PhD degree with extensive demonstration of pharmaceutical experience and related Regulatory experience, including fellowship experience;
• Experience interacting with the EMA, MHRA and other European health authorities;
• Experience with Scientific Advice and Paediatric Investigational Plans;
• Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document;
• Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives;
• Experience in successfully leading teams and the ability to broadly represent Global Regulatory Strategy on project teams;
• Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines;
• Working knowledge of relevant drug laws, regulations and guidance's/guidelines.