Senior Director, Regulatory Affairs
Altasciences(5 months ago)
About this role
The Senior Director, Regulatory Affairs at Altasciences leads regulatory strategy and execution for early-stage drug development, focusing on first‑in‑human and first‑in‑class molecules. This role oversees a team of regulatory professionals, serves as the primary liaison with health authorities such as the FDA, EMA, and Health Canada, and collaborates across clinical, manufacturing, and project teams to ensure compliance and successful submissions.
Required Skills
- Regulatory Strategy
- Client Engagement
- Team Leadership
- Agency Liaison
- Submission Preparation
- Risk Assessment
- GMP
- GLP
- GCP
- Communication
+1 more
Qualifications
- PhD in related discipline
About Altasciences
altasciences.comContract research organization specialized in seamless, end-to-end, early phase drug development, we act to get your most promising compounds into and through early phase clinical trials.
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