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Reference # : 17-82257 Title : Job opening :: Regulatory Associate :: Woodcliff Lake, NJ
Location : Woodcliff Lake, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 10/30/2017 / 10/29/2018  
Job Title: Regulatory Associate
Working Hours: Part-time 3 days per week.
Duration: Woodcliff Lake, NJ
Client: A Big pharmaceutical Company

The candidate should have 3-5 years experience independently compiling routine submissions to an IND and NDA. This would include, but not limited to, maintenance submissions such as, new and updated investigator submissions, new protocol and protocol amendments, Annual Reports (DSURs, NDA) and Investigator Brochure's. The candidate would organize the submission documents, author the cover letter and accompanying required forms in our Documentum based regulatory environment. Following publishing, the candidate would verify and approve the submission for dispatch via the FDA Gateway. Proficiency in Word is required.

Must work on premises.

Interested candidates can send their updated resumes on and you can also reach me at 973-967-3431.