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Regulatory Affairs Specialist - CMC - (New York, NY)

Duties: Author Module three submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements (PAS), Changes Being Effected (CBE-0 and CBE-30), and annual reports. Compile, review, and submit DMF annual updates, amendments, letters of authorization, and customer notifications. Participate in team meetings as a representative of IA with both internal and external cross-functional project teams. The Regulatory CMC Technical Associate may be called upon to author technical reports. The applicant must be able to adhere to local and global SOPs to meet pre-established project milestones and timelines Requirements: BA/BS in a scientific discipline - Chemistry or Biology are preferred Master's Degree a plus 4+ years of pharmaceutical regulatory affairs experience Good knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience Ability with Ms office, Electronic Document Management Systems


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Posted in New York, NY, Science & Research
From Get It, LLC - 1 month ago