Bay Area Senior Manager / Associate Director Regulatory Affairs Opportunity
One of our key mid-sized biotech clients is seeking a dynamic Senior Manager / Associate Director of Regulatory Affairs to become an integral part of their team.
This pivotal role will have you steering regulatory strategies innovative endocrinology pipeline. Join a company that is not only financially stable with a successfully marketed product, but also has a highly collaborative team with great work-life balance.
Responsibilities :
- Develop and implement regulatory strategies for clinical studies, focusing on endocrinology clinical trials
- Engage with health authorities, addressing queries from both US and global agencies
- Contribute across early and late development phases, as well as life cycle management
- Play a critical role in shaping the strategy for regulatory submissions
Requirements :
- Bachelors Degree required, advanced degree (MS, PhD, PharmD, etc) preferred
- 5+ years of biotech / pharma experience within regulatory affairs
- Experience in endocrinology, neurology, or rare diseases is highly desirable
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