Senior Manager, CMC Regulatory Affairs-Biologics Job in New Jersey (NJ), Regulatory Affairs Career, Jobs in Amicus Therapeutics
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Senior Manager, CMC Regulatory Affairs-Biologics job in Cranbury

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Amicus Therapeutics jobs
New Jersey (NJ), Cranbury
Job Code:  417
Employer:  Amicus Therapeutics
Category:  Regulatory Affairs

Location
Country:  United States
State:  New Jersey (NJ)
City:  Cranbury
Map: 
08/28/2018

Description


Senior Manager, CMC Regulatory Affairs - Biologics

Position Summary
The Senior Manager, CMC Regulatory Affairs (Biologics) will support and manage the CMC regulatory activities associated the biologic products of Amicus Therapeutics throughout the lifecycle with minimum supervision. He/She is responsible for the integration of the regulatory CMC strategy of all submissions.
Roles and Responsibilities
- Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports and agency meeting briefing documents in accordance with applicable regulations
- Manage all the regulatory submission documents and the associated supporting documents
- Develop and maintain submission timelines for CMC related issues
- Act as liaison between Regulatory Affairs and other functional areas
- Represent Regulatory Affairs in cross-functional team meetings
- Translate regulatory requirements into practical, workable submission plans
- Provide thoughtful & accurate comments during document review per regulatory guidelines
- Review and communicate current and emerging regulatory requirements
ref: (417)
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