Accessibility Links

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! 

Similar jobs
Senior Medical Director - Medical Communications
  • Job type: Permanent
  • Location: New York
  • Salary: $140000 - $160000 per annum, Benefits: Healthcare + Bonus + PTO
  • Description Job Summary:  High Growth Medical Communication agency looking for a Senior Medical Director (Full Time) to produce leading scientific content in a variety of...
Quality Engineer
  • Job type: Permanent
  • Location: Zürich
  • Salary: 90000 chf -130000 chf
  • Description My client is looking for a Non-Active Devices Engineer based in St Gallen, Switzerland. This is a very exciting opportunity to work with a rapidly...
Quality Director
  • Job type: Permanent
  • Location: Hamburg
  • Salary: €125000 - €145000 per annum, Benefits: 15% bonus
  • Description My client is looking for a Quality Director based in Germany, Hamburg. This is a very exciting opportunity to work with a rapidly growing entity...
Regional Account Specialist
  • Job type: Permanent
  • Location: Minneapolis
  • Salary: $100000 - $115000 per annum
  • Description EPM Scientific are currently looking for a Regional Account specialist to join a Global Notified Body based in the Minneapolis region. This would be a...
Sr. Medical Science Liaison
  • Job type: Permanent
  • Location: Ohio
  • Salary: $150000 - $170000 per annum
  • Description