The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy
Job Summary
The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy.
Responsible for directing global and EU regulatory strategies for assigned projects and programs, including supporting development of the CDP and directing global life cycle management.
As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
Matching Summary
The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy.
Skills & Requirements
Must-have
Global and EU regulatory strategies
Late-stage development regulatory experience
Lead global regulatory submission process
Interface with regulatory authorities
Nice-to-have
Collaborative leader
Cross-functional environments
Multicultural and multinational contexts
Mentoring and supervising others
Key Requirements
Degree in Life Science or related discipline
8 years pharmaceutical/biotechnology industry experience
Minimum of 6 years in Regulatory Affairs (Strategy)
Extensive experience with clinical and pre-clinical regulatory aspects