Job: Regional Regulatory Affairs Senior Associate Contract: 12 Month Contract Location: Remote with occasional presence in Cambridge or Uxbridge Company: A Global biopharmaceutical company About the Role Join a dedicated team of regulatory professionals providing expert regional regulatory leadership and execution across Europe.
This role focuses on the development, registration, and lifecycle management of innovative pharmaceutical products.
We thrive on the challenges of leading cutting-edge regulatory initiatives and collaborate cross-functionally to deliver optimal strategies and successful regulatory authority interactions.
Your Mission In this pivotal role, you will contribute to regulatory activities for one or more products, supporting or independently leading initiatives under the guidance of experienced regulatory professionals.
Key Responsibilities : Implement regional regulatory strategies and plans.
Prepare and manage documentation for clinical trial applications, marketing authorizations, and lifecycle management.
Ensure regulatory compliance across assigned products.
Work within established policies, SOPs, and document management systems.
Foster communication and collaboration across functional and regional teams.
Drive efficiencies in execution across multiple countries.
What We're Looking For We value diverse perspectives and seek a collaborative, detail-oriented professional with: Bachelor's degree in a scientific field with at least 2 years of relevant experience.
Regulatory or region-specific experience.
Experience working with CTA submissions.
Global submissions experiences.
Strong knowledge of regional regulations and legislation for medicinal products.
What We Offer We are committed to fostering an inclusive, supportive environment where innovation thrives.
Expect opportunities for professional growth, flexible work arrangements, and a community where your contributions make a difference.