Global Regulatory CMC Director: Strategy & Submissions
regulatoryEast Boston (MA)
Global Regulatory CMC Director: Strategy & Submissions
Posted today
regulatoryEast Boston (MA)
SENIORITY
Manager
About the role
Takeda is seeking a Senior Regulatory CMC Leader to oversee regulatory submissions for GRA CMC products, guiding content strategy and reviews to meet global requirements. The role involves representing GRA CMC in Health Authority meetings, mentoring team members, and ensuring regulatory compliance across development and lifecycle activities.
The position requires a strong track record in NDA/MAA submissions, cross-functional collaboration, and excellent communication skills to drive successful
Before you apply
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Your profile is current
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Two examples you can talk through
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A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
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Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.