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Senior Regulatory Affairs Specialist, Development
12 hours ago
Role Overview
As a Senior Manager, Regulatory Sciences, you will lead client projects, ensuring efficient project execution and contributing to larger projects.
Key Responsibilities
- Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments and marketing authorisation applications.
- Project manage assigned projects, including approval of time entry and invoicing, budget monitoring, and client liaison.
- Provide expert guidance and technical expertise, manage complex tasks, and contribute to overall project strategy.
- Build strong client relationships, manage expectations, and participate in client strategy discussions.
Requirements
- Advanced degree (MSc/PhD) in a relevant field preferred.
- Bachelor's degree in a life science field or related discipline necessary.
- 8-10+ years' experience within regulatory sciences for development products preferred.
- Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies.
- Experience leading and delivering successful projects within budget and timeframe.
- Demonstrated leadership and client-facing skills.
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