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Senior Regulatory Affairs Associate

  • Job type: Permanent
  • Location: Pine Brook
  • Salary: Competitive
  • Job reference: MSLN080717602
  • Sector: EPM Scientific, Regulatory
  • Date posted: 07/08/2017
One of the United States leaders in Pharmaceuticals is looking for a Senior, Regulatory Affairs Associate to join one of the most innovative Regulatory teams in the USA.
The Senior Regulatory Affairs Associate will be required to review controlled documents for conformance to regulatory requirements. The candidate will be expected to share their knowledge and experience and provide guidance to other associates and co-workers. The candidate will be responsible for communicating with the FDA and representing the regulatory affairs department in internal and external meetings. There will also be exposure to submissions, ANDA, and generics. Any previous experiences in these areas are highly valued. The ideal candidate will have the following responsibilities:
  • Provide regulatory support and advice across the organization
  • Attend project meetings and update functional leads while maintaining transparency of information across the department
  • Putting together documents and submitting to the FDA in relation to FDA standard
  • Authoring and preparing submissions, including NDA,ANDA, and IDE.
Requirements:
  • A minimum of 3-5 years’ experience in Regulatory Affairs
  • A minimum of a Bachelor’s degree, preferably in a scientific related discipline
  • Experience with Adobe Acrobat and Windows-based programs; such as Microsoft Word, Excel, and SharePoint
  • Highly motivated, detail oriented, and self-motivated
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