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Regulatory Affairs Specialist

Kelly Services


Location:
Cherry Hill, NJ
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US51FPAG_BH1434517
Categories:
  • Legal
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Job Details

Job Title Regulatory Affairs Specialist

Jobid US51FPAG_BH1434517

Location: Cherry Hill, NJ, 08034, USA

Description **Regulatory Affairs Associate**

6+ Month Contract

Cherry Hill NJ

Responsible for the preparation of ANDAs, amendments, and supplement applications to OGD and FDA for approval, which includes responding to any deficiency letters related to ANDA submissions.

Responsibilities:


+ Reviews labeling for new products and revisions for existing products.
+ Proofreads labeling drafts as requested by labeling.
+ Completes regulatory portion of Annual Product Reviews (APRs).
+ Reviews Change Control Requests (CCRs) and provides regulatory opinion with supervisor concurrence.
+ Participates in multidisciplinary project teams for new products.
+ Provides regulatory advice to teams and gives updates at regulatory staff meetings as needed.
+ Prepares annual reports, annual product reviews and writes periodic bulletins, prepares supplements, amendments, and other correspondences.
+ Participates and becomes involved with various tasks force teams, as designated by the manager and will act as regulatory liaison to specially assigned R & D project teams.
Qualifications:


+ Exercise independent judgement
+ Scientific knowledge
+ Written and verbal communication skills
+ Strong negotiation skills
+ Technical system skills (ie: word processing, spreadsheets, databases, online research)
+ Manage multiple projects and deadlines
+ Ability to identify compliance risks and escalate when necessary
Education and Experience:


+ BS Degree in a scientific discipline with 2 to 5 years experience in the Pharmaceutical Industry along with excellent communication skills required. Two (2) years of regulatory experience is preferred.
**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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