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Project Manager for Regulatory CMC
Ref No.: 17-01501
Location: Hopewell, New Jersey
Position Type:Contract
Start Date: 10/30/2017
PROJECT MANAGER FOR REGULATORY CMC
HOPEWELL. NJ

Required Skills:
  • Minimum BS degree in Chemistry/Biochemistry, Chemical Engineering, Pharmacy, Biology or related science. Minimum of 2-5 years of experience in the Pharmaceutical Industry with CMC submission experience.
  • Pharmaceutical background with knowledge of CMC regulations and guidances is required.
  • Will have demonstrated ability to be a strong team member with the ability to drive projects to completion on time while providing innovative new solutions to changing deliverables.
  • Requires good organizational, communication, electronic systems and project management skills.
  • Candidates should have the ability to manage multiple projects independently.


Project Description:
  • Will be responsible for preparing CMC documents for global regulatory submissions in alignment with company objectives.
  • Will have responsibility for executing a global regulatory submission strategy for manufacturing changes, annual reports and coordinate responses to health authority questions within agreed upon timelines.
  • Requires strong interaction with Global Manufacturing and Supply personnel at manufacturing sites and other key partners both internal and external to the company.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01501
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE