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CMC Regulatory Submission Project Manager

Alpha Consulting Corporation

Location:
Hopewell, NJ
Posted Date:
5/14/2014
Position Type:
Contract
Job Code:
14-00468
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Pharmaceutical,

Job Description

CMC REGULATORY SUBMISSION PROJECT MANAGER

REQUIREMENT #14-00468
RECRUITER:  CINDI PISNOY
JOB LOCATION:  HOPEWELL, NJ
MAY 14, 2014


Project Description:  The candidate will be responsible for preparing CMC documents for global regulatory submissions in alignment with company objectives. The individual 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. This position requires strong interaction with Global Manufacturing and Supply personnel at manufacturing sites and other key partners both internal and external to the company. Candidates should have the ability to manage multiple projects independently.

Requirements:  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 guidance’s is required. The candidate 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. This position requires good organizational, communication, electronic systems and project management skills.




This 8+ month position starts ASAP.

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

Requirements

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 guidance’s is required. The candidate 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. This position requires good organizational, communication, electronic systems and project management skills.

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