Regulatory Affairs Specialist – Filled

Regulatory Affairs Specialist

Regulatory Affairs Specialist from The Wellington Group

The Wellington Group has been engaged to find a Regulatory Affairs Specialist for a growing and profitable biologics, pharmaceutical and animal health company. Put your RA expertise to work today in a great new job! The Regulatory Affairs Specialist will be involved with both pre and post-marketing duties in support of the Regulatory Director and QA Manager. Under general supervision, the RA Specialist will gather data/information and draft correspondence for transmission to FDA, USDA and other government regulatory agencies as well as some key internal regulatory reports. Responsibilities include:

  • Preparation of various FDA and USDA annual reports for approved products
  • Establishment registrations, NDC assignment, state licenses, and other related regulatory reports
  • Assist with the preparation and compilation of IND Annual Reports
  • Responsibility to submit all scheduled submissions on the regulatory calendar on time
  • Preparation of internal regulatory reports, for example Annual Product Reviews
  • Assist with BLA, MAA, and supplements preparation as requested
  • Perform other regulatory related assignments as requested by the Director of Regulatory Affairs
  • Assist with administrative needs for the department as needed

The qualified Regulatory Affairs Specialist candidate will have:

  • Minimum of 1-3  years regulatory experience is required
  • 4-year degree required, life scientific degree preferred
  • 1-3 years in a GMP environment
  • Knowledge of the regulations governing pharmaceutical products in U.S. is required

Industry: Biologics, Biotechnology, Pharmaceuticals, Regulatory Affairs Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. Don’t wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( 910-338-2795

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