| Regulatory Affairs Specialist |
Job Id: W229301 |
Posted On: 11/25/2009 |
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Location: Hickory, NC;
Job Type: Full Time
Salary: $35000.00 to $50000.00/year
Degree: Bachelor
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DescriptionRegulatory Affairs Specialist Biologics
We have been engaged to find a Regulatory Specialist with experience supporting various regulatory activities from submissions to labeling. This is an exciting new position within a well established, profitable pharmaceutical / biologics company.
The RA Specialist will be involved with both pre and post-marketing duties in support of the Regulatory Director and QA Manager. Will consider individual from pharmaceutical, medical devices, veterinarian and biologics companies.
Responsibilities include:
Draft correspondence for transmission to FDA, USDA and other government regulatory agencies
Assist in authoring various post-marketing FDA and USDA annual product reports, establishment registrations, state licenses, and other related regulatory reports
Assist with preparation and compilation of regulatory submissions including IND, BLA, MAA, and supplements
Maintain Regulatory Affairs files and regulatory correspondence log
The qualified candidate will have:
Minimum of 1 year regulatory experience is required
4-year degree required, life scientific degree preferred
1-3 years in a GMP environment
Aseptic or sterile based manufacturing knowledge is ideal
Industry: Biologics, Biotechnology, Pharmaceuticals
Permanent position with an employee centered company offering great benefits, salary, and relocation assistance.
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