Regulatory Affairs Specialist

  • Location
    Parsippany, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Pharmaceutical Preclinical Development

A Regulatory Affairs Specialist job near Parsippany, NJ is expected courtesy of Adecco Medical and Science. This is an anticipated entry to junior level contract, or temp to hire opportunity, with a recognized pharmaceutical leader.

Regulatory Affairs Specialist job responsibilities include but are not limited to:

Support team members in writing NDAs, ANDAs and other approval materials, including but not limited to PAS, CBEs, and annual reports, for submission to the FDA
Upgrade databases, help with label preparation, and assist with review activities under the Regulatory Affairs supervisor; assist the DMF team with conversion from paper to eCTD
Evaluate, coordinate, maintain, and improve upon regulatory documents management, filing and tracking systems; ensure regulatory database and chronologies for completeness and easy retrieval
Participate in research of regulatory issues and dissemination of regulatory information to production, QA/QC, R&D departments, and management as required


QUALIFICATIONS:

Bachelor Degree or higher; scientific or regulatory background preferred
2-5 years of pharmaceutical and regulatory experience
Previous regulatory affairs contract work preferred; knowledge of CFR and FDA Guidance procedures desired


If you are interested in this Regulatory Affairs Specialist job near Parsippany, NJ then please click APPLY NOW. For other opportunities, available at Medical and Science go to www.adeccousa.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_106405_315203