Regulatory Sciences Project Lead
12 hours ago
Company Overview
ProPharma has improved patient health and wellness by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies.
Job Description
Senior Manager, Regulatory Sciences - DevelopmentAs the world's largest RCO, ProPharma partners with clients through an advise-build-operate model across the complete product lifecycle.
Responsibilities
- Independently lead discreet client projects, and lead project teams through all project phases.
- Author global nonclinical/clinical aspects of regulatory documentation, including orphan designations and paediatric investigation plans.
- 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.
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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