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Senior Regulatory Publisher (contract)

  • Job type: Contract
  • Location: Woodcliff Lake
  • Salary: Competitive
  • Job reference: AC/NY/RegPub
  • Sector: EPM Scientific, Regulatory
  • Date posted: 02/08/2017
Senior Regulatory Publisher (contract)

My client in New Jersey is looking to bring a Senior  Regulatory Publisher onto the team for 1 year! The Senior Regulatory Publisher will be responsible for providing document/sequence level publishing and complication of regulatory submissions. 

My client is a mid-size pharmaceutical company that is growing – but not too fast where it is unstable! It’s a great time for a regulatory person to join the team and make a major impact in a senior level role.

 Responsibilities 
  • Gather/prepare essential documents required for US and global regulatory submissions
  • Make sure all submission content is accurate
  • Ensure documents are submitted in accordance with ext. regulatory and int. standards
  • Publish electronic submissions in eCTD format for FDA, EMA and other regulatory agencies
Requirements
  • Bachelor’s degree in a life sciences related field
  • MUST have 3+ years of Regulatory Affairs publishing experience (in pharma, biotech, or CRO environment)
  • Proficient with ISI Toolbox
  • Good working knowledge of European regulatory requirements
 
Apply now! 

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