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Senior Director, Global Regulatory Lead Neuroscience
$226,750–$313,460 year
On-site · Princeton, New Jersey, United States or Allston, Massachusetts, United States
Job Summary
Senior Director, Global Regulatory Lead Neuroscience responsible for developing global regulatory strategies and operational plans for identified neuroscience assets, serving as the primary global regulatory interface with health authorities, coordinating submissions with regulatory product managers and regional teams, guiding development plans, and influencing regulatory strategy across projects to enable development and commercialization in collaboration with cross-functional partners.
Required Qualifications
- Advanced degree in scientific discipline; MD, PhD or PharmD preferred
- 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs
- Global experience strongly preferred with command of US experience and EU background desired
- Thorough knowledge of the drug research, development, and commercialization process
- Demonstrated specific expertise in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes
- Sensitivity and experience with non-domestic organizations/cross-cultural environments
- Excellent organizational, communication and time management skills
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