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in North Versailles, PA
Associate Director, EUCAN Regulatory Lead, Neuro Science - Full-time / Part-time
North Versailles, PA 15137
30 days ago
Hours
Full-time, Part-time
About this job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description- Collaborates to define, develop and lead regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
- Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Is the Regional Working Team and represents the region as needed on global and project teams
- Provides regional regulatory expertise for assigned development and/or life cycle management project(s) within the therapeutic area of responsibility
- Manages and oversees interactions with EMA and national health authorities and HTAs (jointly with value and access team in context of parallel consultation) in the Europe Region for products within their responsibility.