Regulatory Associate

Regulatory Associate – Pharma

Term: 12 Months ~ This is a Part Time position, on site 3 days/week

Location: Woodcliff Lake NJ

 

  • The candidate should have 3-5 years’ experience independently compiling routine submissions to an IND and NDA.
  • This would include, but not limited to, maintenance submissions such as, new and updated investigator submissions, new protocol and protocol amendments, Annual Reports (DSURs, NDA) and Investigator Brochure’s.
  • The candidate would organize the submission documents, author the cover letter and accompanying required forms in our Documentum based regulatory environment.
  • Following publishing, the candidate would verify and approve the submission for dispatch via the FDA Gateway.
  • Proficiency in Word is required.
  • Accepted file types: doc, pdf, txt, docx.