CMC Regulatory Manager - Clinical Research - Central NJ - 4 month opportunity!

Kelly Clinical Resources is seeking a CMC Contract Regulatory Manager to assist with NDA Annual Reports and other routine CMC registration activities. This is a 4 month contract opportunity with a major pharmaceutical company in Central New Jersey. This position requires Regulatory CMC background or a strong QA/Compliance background.

Job Description:
Contract Regulatory Manager needed for preparation of CMC section of NDA Annual Reports, and for assisting with other routine NDA, IND and DMF registration activities.

Ideal candidate should have knowledge of US registration requirements and be familiar with FDA and ICH guidelines relating to CMC for pharmaceutical products.

Job Requirements:

Regulatory CMC background, or a strong QA/Compliance background required.

The ideal candidate should also be familiar with Documentum, and have excellent communication and technical writing skills.

Background in areas of Quality Assurance/Compliance, drug product/drug substance stability, GMP auditing are also beneficial.

BS in a relevant discipline.

QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!

Kelly Scientific Resources(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.Kelly Services is an Equal Opportunity EmployerContact?Information?:.140 Route 17 North, Ste 314
Paramus?NJ?07652