Title: Director, Regulatory Global Strategy - Neurology
Company Summary: Join a growing pharmaceutical company with over 10,000 employees worldwide focused on developing their neurology and oncology portfolio. This position will focus on all aspects of global regulatory strategy from early development through post approval. Interacting directly with global Health Authorities as well as successful preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs will be crucial as the Director of this quickly evolving team.
The Director of Global Regulatory Strategy will be responsible for:
* Acting as the Global Regulatory lead (GLR) for all responsibilities assigned to the portfolio
* Constantly creating and updating all aspects of regulatory strategy as they apply to domestic and global guidelines
* Having a strong knowledge of FDA guidelines, changes, and updates on a global level
* Conducting meetings with Health Authorities/submitting proper documentation of the highest quality
* Cross functionally working with multiple branches to ensure smooth and efficient processes
Requirements of the Director, Global Regulatory Strategy:
* BS in a scientific discipline (Masters preferred)
* 10+ years of industry regulatory strategy experience
* Preparation of IND/CTA/sNDA/Type II variation submissions is needed
* Exposure to successful NDA, MAA and/or BLA filings preferred
* Demonstrated ability to think strategically in drug development settings
* Ability to travel 10% based on business needs