Europe Regulatory Strategist
Core
Lead and implement regional regulatory strategies for drug development projects to ensure timely submissions and approvals with commercially attractive labeling in assigned regions (US, EU, or EM).
Role type
Senior regulatory strategist (drug development)
Builds
Regulatory strategies, submission plans, and labeling for medicines and vaccines
Domain
Pharmaceuticals / Life Sciences
Required skills
Regional regulatory strategy, drug development lifecycle management, health authority interaction, IND/CTA/NDA/MAA/IRD preparation, risk register management, cross-functional partnership
Preferred skills
FDA or major EU agency experience, therapeutic area diversity, electronic submission systems, AI tool usage (ChatGPT/Copilot)
Technologies
Regulatory information management systems, generative AI tools
Responsibilities
Represent a specific region for regulatory sciences, lead regional regulatory strategies in alignment with commercial goals, ensure optimal interactions with Health Authorities, contribute to global regulatory strategies and implementation plans, monitor regulatory plans and mitigate risks, align regional regulatory positions for key issues, influence the regional regulatory environment through agency contacts and trade associations
Seniority
Senior, hands-on IC