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Generic SR Regulatory Affairs Associate - Scientific

Posted:  November 5, 2009

Jobs  Scientific  New York  Generic SR Regulatory Affairs Associate

Generic SR Regulatory Affairs Associate

Company: Aerotek Scientific Location: Melville, New York Category: Scientific Jobs Rate: Based on experience. Job Type: Full-Time Posting ID: 1993721 Posting Date: 10/28/2009 Allegis Group Family of Hiring Companies

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Generic SR Regulatory Affairs Associate Job Description:

Our client, a pharmaceutical company located in Nassau County Long Island, New York is seeking a new member to join their Regulatory team. The Senior Regulatory Affairs Associate will be responsible for managing the preparation and submission of regulatory documentation for generic Regulatory filings. This is a full-time, permanent position with excellent salary and benefits. Relocation assistance will be offered for the right candidate.

Job Responsibilities:

- Preparation of ANDAs in e-CTD format. - Quality documentation and compiling submissions, - Participation in new ANDA project meetings - Preparation and coordination of all aspects of FDA submissions - Function as CMC Project Lead in the group

Requirements:

- Bachelors degree, preferably in the life sciences or a related scientific discipline. - Minimum of 5 years of experience working in a Regulatory Affairs Department and at least 2 years of experience in generic regulatory field with a CMC concentration. - Minimum of 1 year in a lead role within a Regulatory Affairs team. - Experience with the preparation and maintenance of regulatory documents. - Knowledge of electronic submissions in eCTD format. - Must possess excellent attention to detail, including outstanding written and verbal skills. - Ability to work successfully in a fast-paced, team-based entrepreneurial environment.

All qualified and interested candidates should apply online, this is an immediate opening.

Required Skills for Generic SR Regulatory Affairs Associate Job:

* REGULATORY AFFAIRS * CLINICAL PHARMACEUTICAL * GENERIC * ANDA

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, were constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.

Contact Information

Pinar Senyilmaz  Apply Now! Begin by filling out the "Apply Online for this Job" section at the top of the page Need Directions? Get office driving directions with Google Maps psenyilm@aerotek.com Aerotek Scientific - New York, NY II 757 3rd Ave. Suite 201 New York, NY  10017

TEL: (212) 588-5872

Please refer to job code 1993721 when responding to this ad.

Category:Biotech/Pharmaceutical
     > Regulatory Affairs
Location:Melville, NY
County:Suffolk County
ZIP Code:11747
Pay Rate:Open
Job Terms:full time
Company:Aerotek
Phone:email only please
Fax:email only please

 
 
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