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Manager, Regulatory Affairs

  • Job type: Permanent
  • Location: Pine Brook
  • Salary: £110000 - £130000 per annum
  • Job reference: JEAO3218518
  • Sector: EPM Scientific, Regulatory
  • Date posted: 02/03/2018
RA Manager required for Global Bio-pharmaceutical Company
  • RA Manager | Generics
  • Greater NYC Area
  • $110,000 - $130,000 + excellent bonus + excellent benefits
A thriving and innovative pharmaceutical company, which specializes in generics products, is looking to speak with an experienced leader within RA to lead a group of associates in regulatory activities associated with planning, authoring and submitting regulatory reports to the FDA.

The successful incumbent will plan, coordinate, and review submissions to the FDA ensuring internal compliance with Regulatory guidelines and ensure all deadlines are met for regulatory milestones.

Responsibilities:

  • Prepare and compile new ANDAs, Amendments, Supplements, and Annual Reports
  • Critical review of documentation intended for submission to the FDA
  • Participate in the establishment of project deadlines and ensure KPIs are met
  • Promote sound strategies in support of submission goals
 Qualifications:
  • Minimum of BS in life science, MS in RA or equivalent preferred
  • Minimum 7 years pharmaceutical industry experience with 5 years in RA
  • 2 years of previous supervisory experience
  • Experience with Generics highly desirable
 

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