What are the responsibilities and job description for the NVG- Regulatory CMC, Associate Manager -185 position at NewAge Clinical?
State :
New Jersey
Date :
Apr 6, 2022
Experience Level :
Position Type :
Regulatory CMC, Associate Manager
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.
Work Location: East Hanover, NJ
Job Title: Regulatory CMC, Associate Manager
Duration: 12 months (extendable) contract on W2
Duties:
Provide regulatory and operational support to department in accordance to defined requirements to guarantee timely preparation of high quality CMC regulatory submissions and associated compliance information throughout the life cycle.
a. Support global regulatory CMC submission activities.
b. Provide regulatory support on projects/products covering development, registration and approval/post approval.
c. Author and/or review CMC documentation for Health Authority submissions.
d. Perform compliance and operational support including document QC and format checks
e. Create submission documentation such as folders, metadata forms, RA request forms
f. Ensure documentation is eCTD compliant, Document formatting (DA) checked, finalized and eCTD filenames assigned.
g. Support business objectives and initiatives.
Skills:
a. 1-3 years of pharmaceutical industry experience in regulatory CMC with a working knowledge of global regulatory requirements.
b. Experience working with regulatory submissions is preferred.
c. Effective planning, organizational and interpersonal skills as well as good oral and written communication skills.
Education:
a. Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Pharmacy) or equivalent
b. Desirable: Advanced Degree in Science
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Many Thanks,
Sree Kanth
Recruitment Manager
Sree@newageclinical.com
NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3
Princeton , NJ 08540
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