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| Regulatory Affairs Specialist - Job # 1943 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position in based in Caldwell County, NC.
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Essential Duties and Responsibilities:
We are currently hiring a Regulatory Affairs Specialist for our Client. This incumbent will be responsible for gathering data/information and drafting 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.
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Requirements
- Bachelor degree majoring in Life Sciences is required.
- 1-3 years experience in a GMP environment and 1-3 years experience in a Regulatory Affairs role.
- Good analytical and problem solving skills; scientific and/or technical knowledge.
- Effective writing and verbal communication skills
- Excellent computer skills including: advanced MS Office skills and proficiency with Adobe Acrobat is required.
- Some knowledge of the regulations governing pharmaceutical products in U.S. is required.
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 For confidential consideration please submit a resume and salary history to
claire@fullscalesolutions.com.
Full Scale Solutions is an Equal Opportunity Employer.
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