Please scroll down, To apply

Senior Regulatory Affairs Specialist

hiring now

Jobot

2021-12-03 07:37:32

Job location Lexington, Kentucky, United States

Job type: fulltime

Job industry: Government & Defence

Job description

Looking for a Senior Regulatory Affairs Specialist with pharma/biotech experience

This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.

A bit about us:

Based in Lexington, KY, we are a specialized pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray medicines. We collaborate on the development of products with our clients and manufacture at commercial scale for the US and European markets. We are looking for a Senior Regulatory Affairs Specialist to join our rapidly growing team.

Why join us?

  • Competitive Salary!
  • Extremely Competitive Benefits Package!
  • The Opportunity to Join an Amazing Team!


Job Details
  • Bachelor's degree in engineering or a scientific discipline required. Master's degree in regulatory affairs/regulatory science a plus.
  • At least 5 years Pharmaceutical/Medical Device cGMP regulatory experience, medical device experience strongly preferred.
  • Direct knowledge in preparation of regulatory dossiers (510K, PMA, IND, ANDA, NDA, BLA, etc.).
  • Working knowledge of US and EU regulations and guidance documents.
  • Ability to work independently with minimal oversight as well as collaboratively with cross functional teams.
  • Excellent technical writing, communication and organizational skills.
  • Exceptional interpersonal skills and the proven ability to work well with cross functional teams to meet performance requirements.
  • Working knowledge of cGMPs, cleanrooms, and pharmaceutical processing and plant equipment.
  • Self-starter with outstanding work ethic; must be able to perform in a fast-paced, dynamic, multi-project environment.
  • Proficient in project management.
  • Regulatory Affairs Certification (RAC) a plus.
  • Qualified to work with controlled substances.


Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. - provided by Dice

Inform a friend!

Top