Regulatory Operations Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Labelling & Artwork, Operations
  3. United States
Princeton, USA
Posting date: 13 Aug 2020

Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company located in Princeton, NJ.

Job Responsibilities:

  • Facilitate all aspects of US drug listing compliance including content of Labelling/ SPL Generation, review, submission, updates to listing with new artwork, labeler codes, establishment registrations, etc.
  • Assist in data migration and integration activities, as well as maintenance of all regulatory documents, and records in a controlled environment.
  • Proofreads internal and external material to ensure accuracy of labelling content and company format.
  • Strong drug listing expertise.
  • Documentation management experience.
  • Attention to detail, with excellent organizational, interpersonal and communication skills, both written and verbal.
  • Clear communication.
  • Experience with A4L or other third-party vendor software a plus.
  • Ability to multitask, work independently and remotely within set timeframes.
  • Performs related duties as assigned.

Skills and Requirements:

  • Bachelor's degree required. Advanced degree preferred.
  • 4 years pharmaceutical industry experience.
  • Experience with OTC products a plus.
  • Remote position but must work in Eastern Standard Time.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.