Regulatory Affairs Manager

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POST DATE 9/16/2016
END DATE 11/1/2016

Engineering Resource Group, Inc. East Hanover, NJ

East Hanover, NJ
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Full Time
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Company Ref #
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per year


Regulatory Affairs Manager to complete regulatory correspondence, review and assemble IND and NDA submissions, and develop regulatory strategy. Position is with a growing pharmaceutical company in northern NJ. Specific responsibilities include: - Develop regulatory strategy for US drug approvals. Establish contact with the FDA.- Complete FDA submission documentation with cover letters.- Ensure clinical trial information postings are complete and up to date.- Provide support to senior regulatory personnel for IND and NDA submissions by preparing, formatting, and reviewing sections.- Serve as point of contact on topics of regulations, key issues, risks and other critical topics to maintain regulatory compliance.- Provide leadership to regulatory project teams.


- Chemistry, Pharmacy, Biochemistry, Biology or other science degree plus
5+ years regulatory experience in a pharmaceutical company.- Experience
in regulatory submissions, knowledge of drug regulations, and the ability
to apply to complex regulatory requirements.- Experience interacting with
FDA and other Health Authorities.- Experience providing regulatory submissions
in Electronic Common Technical Documents (eCTD).- Familiarity with national
and international standards including CTD, ICH, and GCP.- Detail-oriented
with good organizational skills to plan, coordinate and lead activities
on multiple projects.- Excellent interpersonal skills to scientific information.
Excellent written and verbal communication skills.

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