Global Regulatory Strategy Lead
1 day ago
Regulatory Affairs Director
Overview:The Regulatory Affairs Director will lead the development and submission of regulatory documents, provide strategic direction, and negotiate with agencies to expedite approvals.
- Develop and implement global regulatory strategies across major regions
- Contribute strategic input into global regulatory plans, identifying risks and contributing to key planning documents
- Collaborate with cross-functional and regional teams to align regional regulatory approaches with global objectives
- Manage Health Authority interaction strategies, including preparation of briefing materials
- Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans)
- Lead or support negotiations for regional approvals with local HAs (e.g., FDA, EMA)
- Develop strategies to minimize review delays and regulatory clock stops
- Ensure timely and compliant responses to HA queries and requests
- Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field
- Significant experience in regulatory affairs within the pharmaceutical industry
- Proven track record in project management and regulatory operations
- Experience representing the organization in cross-functional and cross-cultural settings
- Strong knowledge of clinical trials, drug development, and regulatory compliance
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