Accessibility Links

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
Similar jobs
Global Publications Manager
  • Job type: Permanent
  • Location: New York
  • Salary: £115000 - £125000 per annum
  • Description We are looking for a Publications Manager to join our client’s industry-leading organization. Our client is located in the Greater New York City area and...
Research Associate (Contract)
  • Job type: Contract
  • Location: Cambridge
  • Salary: Competitive
  • Description A well-known pharmaceutical company in Cambridge is looking to hire a motivated research associate! Requirements -Masters degree in life sciences with at least 1 year...
Senior QA/RA Manager
  • Job type: Permanent
  • Location: Utrecht (stad)
  • Salary: £90000 per annum
  • Description Senior QA/RA Manager required I am currently working on a project with an exciting medical device company, who are going through a growth phase following...
Manager, Medical Writing
  • Job type: Permanent
  • Location: New Jersey
  • Salary: $120000 - $140000 per annum
  • Description Our client is located near Trenton, NJ and is one of the industry leaders in the medical device field! We are looking for an experienced...
Principal Regulatory Writer
  • Job type: Permanent
  • Location: Chicago
  • Salary: $120000 - $135000 per annum
  • Description One of the leading companies in Pharmaceuticals is in search for a talented Principal Regulatory Writer to support their Immunology and Oncology teams. This is...