Accessibility Links

Senior Regulatory Publisher (contract)

  • Job type: Contract
  • Location: Edison
  • Salary: Competitive
  • Job reference: AC/NY/RegPub
  • Sector: EPM Scientific, Regulatory
  • Date posted: 08/11/2017
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! 

Similar jobs
Associate Director Access Manager
  • Job type: Permanent
  • Location: Zürich
  • Salary: Competitive
  • Description Associate Director Access Manager Location: Zurich  With multiple products launches coming up this rapidly expanding pharmaceutical company are looking to strengthen
Senior Test Engineer (IEC 60601)
  • Job type: Permanent
  • Location: Gothenburg
  • Salary: Competitive
  • Description Senior Test Engineer (IEC 60601) - Medical Device Company - Sweden - Gothenburg My client is looking for Senior Test Engineer based near Gothenburg -
International Marketing Director
  • Job type: Permanent
  • Location: Brussels
  • Salary: Competitive
  • Description International Marketing Director  A leading Diagnostic and Imaging Company are looking to add a Senior Marketing Manager to their International Marketing team to be based...
Director of Regulatory Affairs and Quality Manager
  • Job type: Permanent
  • Location: Basel
  • Salary: Competitive
  • Description A leading multi-national Medical Device company is seeking an experienced Quality or Regulatory Manager required to direct their Basel office. The Quality & Regulatory Director...
Senior Medical Writer
  • Job type: Permanent
  • Location: Oxford
  • Salary: Competitive
  • Description Senior Medical Writer Oxford, United Kingdom A leading Pharmaceutical company is seeking an experienced Senior Medical Writer based in Oxford, United Kingdom.  This