Senior Manager, Regulatory Affairs Lead
11 hours ago
About the Role
Senior Manager, Regulatory SciencesProPharma Group is a global leader in regulatory sciences, providing expert advice and solutions to biotech, med device, and pharmaceutical organizations.
Key Responsibilities
- Lead client projects, ensuring efficient project execution and contributing to larger projects.
- Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments and marketing authorisation applications.
- Project manage assigned projects, monitor budgets, and provide expert guidance and technical expertise.
- Build strong client relationships, manage expectations, and participate in client strategy discussions.
- Stay informed of relevant regulatory developments and contribute to workshops, trainings, and calls for collaboration.
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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