EU Regulatory Strategy Lead
2 weeks ago
About the Opportunity
We are excited to announce an opportunity for a seasoned Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the chance to leverage your expertise to drive regulatory compliance and quality in clinical trials.
Key Responsibilities
- Leverage your knowledge of regulatory guidelines and regulations to ensure compliance in clinical trials.
- Develop and execute EU/ROW regulatory strategies for assigned projects.
- Prepare and submit regulatory documents, such as Briefing Packages, ODDs, and PIPs.
- Collaborate with cross-functional teams to ensure alignment and effective communication.
About Us
- We are a global biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment.
- We are committed to fostering a workplace culture that values diversity, equity, and inclusion.
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