Associate Director Regulatory Affairs, Oncology
Core
Develop and execute global and regional regulatory strategies for oncology assets to ensure compliance and optimal labeling across key markets.
Role type
Associate Director, Regulatory Affairs (Oncology)
Builds
Regulatory submission packages and approval pathways for new medicines
Domain
Biopharmaceuticals / Oncology
Deliverable
client delivery
Required skills
Regulatory strategy development, Regional submission management, Clinical trial regulatory requirements, Licensing requirements, Regulatory intelligence assessment
Preferred skills
Oncology (Hematology or Solid Tumor) regulatory experience, Advanced Scientific Degree (PhD, MD, PharmD), Matrix working, Proactive problem-solving, Creative regulatory problem-solving
Technologies
None stated
Responsibilities
Proactively develop regulatory strategy for local regions considering global needs, Implement regional strategies to support global projects, Lead regulatory interactions and review processes in local regions, Ensure compliance with global/regional requirements at all product life stages, Assess regulatory precedent and competitive environment impact on strategy
Seniority
Associate Director, strategic planning & matrix leadership