Regulatory CMC Technical Associate

Job Description: 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

Qualifications: 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 Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3348 | Fax: 973.998.2599 Connect with us on - LinkedIn | Facebook | Twitter

Type: Contract

Function: Research

Experience level: Mid-Senior Level

Industry: Pharmaceuticals