Regulatory Affairs Manager - Contract

  • Location
    Princeton, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Regulatory

An upcoming Regulatory Affairs Manager job near Princeton, New Jersey is anticipated courtesy of Adecco Medical and Science. This is a contract or temp to perm opportunity with a recognized pharmaceutical company. This individual must be an experienced generalist regulatory background, with five to ten years of regulatory experience within biotech or pharmaceutical industry.

Regulatory Affairs Manager job responsibilities include:
• Manage daily operations and communications with regulatory team, streamline processes and resources across different units within assigned regulatory timelines, and provide regulatory counsel concerning clinical trial project requirements.
• Develop effective global regulatory strategies, serve as lead regulatory intermediary with development team, facilitate team meetings communicating progress to management, and implement project milestones prioritizing work duties within specified programs.
• Provide strategic and operational direction and oversight to regulatory projects relating to product development, registration, as well as oversee the regulatory approval process and handle all interactions with regulatory authorities.
• Oversee submissions including but not limited to preparing and writing regulatory documents; address internal SOPs, prepare plans, and manage reporting requirements and issues pertaining to regulatory compliance.

QUALIFICATIONS:
• Scientific Degree; Master’s Degree and other regulatory credentials desired
• Five to ten years of regulatory experience
• Highly knowledgeable of IND applications and FDA requirements
• Excellent communications skills with track record of team leadership

If you are interested in this Regulatory Affairs Manager job near Princeton, 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_310532