Regulatory Operations Electronic Submissions Specialist (Publisher)-Pharma

Location: Central NJ, NJ
Date Posted: 10-18-2016
Job Description : We are looking for a Regulatory Operations Electronic Submissions Specialist for a major, industry leading pharmaceutical company in Central New Jersey.


Support Global Regulatory Operations in coordination, preparation and submission of INDs, NDAs, MAAs and 510ks in eCTD and paper formats
Hands-on Publishing and Verification of regulatory dossier submissions (IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Responses).
Maintain all regulatory and health authority submissions archiving
Verification of regulatory documents in electronic document management system

Bachelor degree in related field Required
Minimum 2+ years of experience in a pharmaceutical company or CRO in Regulatory Operations Required
Minimum 2+ years of experience in publishing and eCTD (electronic) submissions Required
Knowledge of IND, NDA, MAA, CTD requirements and guidelines for electronic and paper Required
Technical knowledge and experience with electronic publishing systems/tools/document management systems/software Required
Proficient with MS Office Suite and Adobe Required
Attention to detail, ability to multi-task
Excellent verbal and written communication
Candidate Must Have : Electronic Publishing experience,2+ years pharmaceutical industry experience,eCTD,Experience with publishing tools, software, systems
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!

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