Regulatory CMC Technical Associate
• Author Module 3 submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements (Client), 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 Keywords: CTD, CMC, eCTD, FDA, Client, CBE, API, DMF, cGMP, templates
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3348 | Fax: 973.998.2599
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