Regulatory Strategy Senior Analyst

Location: Basking Ridge, New Jersey, United States
Salary: US$50 - US$51 per hour + optional benefits package
Job Type: Contract
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A Japanese pharmaceutical organization is seeking to hire a Regulatory Strategy Senior Analyst for a 6-month contract opportunity.

The Regulatory Strategy Senior Analyst will be responsible for 1) assisting with the preparation, coordination and monitoring of routine US regulatory submissions (e.g., IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings) and responses to requests. 2) Provide support to lead product/project strategist(s) in the formulation of regulatory strategy and may liaise with FDA under supervision. 3) Collaborate with other internal functions, company affiliates, and license partners to support clinical trials, new product registrations and maintain existing marketing authorizations globally.

Duration: 6-month contract

Location: Basking Ridge, New Jersey

Compensation: $50-51 per hour

Requirements:

  • Education: B.S. degree, preferably in a scientific discipline.
  • 2-4 years relevant experience in regulatory affairs in the pharmaceutical industry.
  • Team oriented and forward thinking attitude, strong interpersonal and communication skills, and structured, independent work.
  • Understanding of regulatory processes.
  • Ability to plan, coordinate and lead activities simultaneously on multiple projects.

Sthree US is acting as an Employment Business in relation to this vacancy.

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