Regulatory Affairs Manager
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POST DATE 9/16/2016
END DATE 11/1/2016
Engineering Resource Group, Inc.
East Hanover, NJ
JOB DESCRIPTIONAPPLY 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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