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Regulatory Affairs Specialist - CMC

Author Module 3 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 candidate must be able to adhere to local and global SOPs to meet pre-established project milestones and timelines

BA/BS in a scientific discipline - Chemistry or Biology are preferred Master's Degree a plus
4+ years of pharmaceutical regulatory affairs experience
Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience
Expertise with Microsoft Office Suite, Electronic Document Management Systems
Proven experience working with authoring templates and tools
Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines
Required to communicate with management when issues arise
Must have the appropriate technical background and desire to learn and assimilate new information
Proven ability to work independently and as a member of a team
Capable of interacting with technical groups and understand complex issues pertaining to CMC, packaging, and testing
Superior written and verbal communication skills in the English language
Excellent proofreading skills
A working knowledge of cGMPs
The potential candidate may be called upon to provide a writing sample

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Renee, CRC

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