Regulatory Affairs Specialist

  • Location
    Jersey City, New Jersey
  • Job type
    Contract/Temp to Hire
  • Category
    Medical & Science - Regulatory

An upcoming Regulatory Affairs Specialist job near Jersey City, New Jersey is expected courtesy of Adecco Medical and Science. This is an anticipated mid to senior level contract or temp to hire opportunity with a recognized pharmaceutical leader. We anticipate similar opportunities in the greater NYC area in the coming weeks and months.

Regulatory Affairs Specialist job responsibilities may 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 and similar opportunities near Jersey City, New Jersey 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

  • Apply with Adecco

Reference number US_EN_2_106405_324531