Overview
On Site
Depends on Experience
Full Time
Skills
Regulatory
CMC regulatory
MAA
Job Details
Job Title: Regulatory Studio CMS Senior Manager
Location: 100% Onsite New Brunswick (preferred) or Lawrenceville, NJ
Duration: 11 Months Contract
Top Required Skills / Must-Haves:
- 2 3 years of Small Molecule Drug Development experience
- Hands-on experience with Veeva System (Documentum)
- Strong verbal and written communication skills
- 5+ years in the pharmaceutical industry
- 3+ years CMC regulatory experience (Sterile Injectable experience preferred)
The highlights are as below:
- Experience with Veeva System, documentam is must for the candidates
- Small Molecule (marketed products) Drug development experience (2 to 3 years)
- Expert in post approval submissions globally (mainly amendments for FDA, variations EU)
- Able to answer HA questions directly, direct coordination with HAs
- Exp in initial submission for MAA, NDA/IND/ANDAs will be brownie points
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