Regulatory Affairs Manager
1 week ago
Takeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global CMC regulations for advanced therapies and biological compounds.
Key Responsibilities- Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams.
- Participate on and/or lead multifunctional teams to handle and prioritize multiple projects and work independently.
- Provide expertise on worldwide CMC regulatory requirements and successfully deliver dossiers that comply with these, particularly for new medicines in development.
Bachelor's degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills include ability to work with firm deadlines, adapt quickly to changing requirements and priorities, and experience with global CMC regulations.
What We OfferFull-time position with up to 20% domestic travel required and up to 50% remote work allowed. Competitive salary range of $178,500 - $202,000 per year.
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Regulatory Affairs Manager
1 week ago
Lexington, Massachusetts, United States Takeda Pharmaceutical Full timeAt Takeda Pharmaceutical, we are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA.Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams.Participate on and/or lead multifunctional teams to handle and prioritize...
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