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Regulatory CMC Associate - Marketed Products

Company Name:
Artech Information Systems, LLC
Reference # : 14-31150 Title : Regulatory CMC Associate - Marketed Products
Location : East Hanover, NJ
Experience Level : Start Date / End Date : 09/15/2014 / 03/13/2015
Description
Job Title: Regulatory CMC Associate - Marketed Products(4009818)
Location: East Hanover, NJ
Duration: 6 Months
Job Reference Code: 14-31150
Working Hours: 37.50/week
Job Description:
The manager is NOT looking for DRA experience - she needs CMC experience. The team would consider more junior level candidates as well with this experience.
Under supervision, provide strategic and operational global CMC regulatory direction and documentation for MARKETED PRODUCT maintenance. Experience desirable. The following activities may be performed within this capacity:
Provide and/or implement global CMC regulatory strategy for products.
Lead or contribute to global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.
Identify required CMC documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
Contribute to cross-functional CMC Health Authority Response Teams for assigned products and prepare CMC responses, as appropriate.
Assume specialized assignments as assigned.
Skills:
At least 3 years in regulatory project management preferred, and/or experience in drug/biopharmaceuticals
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
Education:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable:
Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
Thanks,
Nidhi Bansal
Senior Executive-Staffing
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email:nidhi. -
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About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,800 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
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