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Regulatory Affairs Associate

  • Job type: Permanent
  • Location: Philadelphia
  • Salary: Competitive
  • Job reference: JEA21418606
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/02/2018
Regulatory Affairs Associate required for PA-based Generics Manufacturing Company
  • Regulatory Affairs | Generics
  • Greater Philadelphia Area
  • Competitive Base + Bonus + Benefits
A Philadelphia based Generics Manufacturing company is actively recruiting for an enthusiastic and process-driven individual to spearhead the submission program for their regulatory department. The successful candidate will work autonomously to author, review, and execute regulatory submissions (i.e ANDAs, NDAs, Amendments, etc.) directly to the FDA.

This company has received immense merit for their overall success in the Generics field and are looking to increase their staff by 15-25% this year.

Responsibilities:
  • Communicate with FDA and represent the Regulatory Affairs department in cross-functional team meetings and must possess a strong understanding of regulations and guidances
  • Assist in determining regulatory strategy for new submissions and post-approval changes
  • Review controlled documents for conformance to regulatory requirements 
Qualifications:
  • A minimum of 3-5 years’ experience in Regulatory Affairs with a generics company is preferred
  • A minimum of a Bachelor’s degree, preferably in Chemistry or a related, scientific discipline
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