Accessibility Links

Regulatory Operations Manager

  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: Negotiable
  • Job reference: 328961/001_1560541016
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/06/2019

Regulatory Operations Manager

My client is looking for a Regulatory Operations Manager on a permanent full-time basis. The Regulatory Operations Manager will be responsible for processing, publishing, contributing to, and managing the regulatory submissions process.

My client is a growing pharma company with various locations across the US. With an approved drug last and a strong current pipeline, now is an exciting time to enter the company.


  • Publish compliant documents (eCTD)

  • Manage submission lifecycles (IND and NDA)

  • Schedule/track eCTD submissions

  • Write/maintain SOPs


  • Bachelor's degree in a life science related field (Master's preferred)

  • 5+ years of regulatory operations experience in the pharma/biotech industry

  • Hands on experience with different electronic submission software

Apply now!

Similar jobs
Project Manager
  • Job type: Permanent
  • Location: New York
  • Salary: £90000 - £120000 per year
  • Description Overview: This position is with a rapidly expanding medical device organization that works to combat addiction. The team is seeking a life sciences professional that has experience working with
Senior Specialist-Structural Heart
  • Job type: Permanent
  • Location: Maple Grove, Minnesota
  • Salary: US$85000 - US$105000 per year
  • Description Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space? My client has been a global medical technology leader for the past 35 years
Senior Staff Specialist, Regulatory Affairs
  • Job type: Permanent
  • Location: San Diego, California
  • Salary: Competitive
  • Description Title: Senior Staff Regulatory Affairs Specialist Company Summary One of the top 10 largest medical companies in the world is looking to grow out their Regulatory Affairs team at the San Diego
Regulatory Affairs Specialist
  • Job type: Permanent
  • Location: Mannheim, Baden-Württemberg
  • Salary: Competitive
  • Description Job Type: Regulatory Affairs Specialist Location: Mannheim A global leader in the innovative medical device industry, paving the way in discovering treatments for patients within the Ophthalmology