Sample Job Description for Regulatory Affairs Manager

Here is a sample job description template for the position of Regulatory Affairs Manager:

Job Title: Regulatory Affairs Manager

Location of the Job: Princeton, NJ 08540

Job Type: Full Time Employee

Years of Experience: 2+ to 7 Years

Job Summary:

A growing, well-funded US subsidiary based in NJ needs an experienced Regulatory Manager to lead submission activities for their new drug!

If you are a Regulatory Affairs Manager, Regulatory Submission Manager, RA Specialist, working in Regulatory Affairs with IND/CTA and NDA experience with a NCE (New chemical entity), please read on!

Duties and Responsibilities:

  • Submitting NDA for a NCE
  • Providing Advertising and Promotional regulatory review support
  • Post approval maintenance of NDA
  • Serving as local Regulatory Affairs Project Leader for Latin America project.
  • Act as Regulatory Lead in the preparation of NDA
  • Overseeing regulatory CRO for ex-us submissions

Position Requirements:

  • Advertising and Promotional experience a must.
  • Bachelor’s degree in Life Sciences and minimum of 5 years broad “hands on” Regulatory Affairs pharmaceutical experience with an emphasis on post-marketed NDA products.
  • eCTD NDA submission experience a +
  • In-depth experience in IND and NDA submission with a New Chemical Entity (NCE)
  • 5+ years of drug regulatory affairs experience
  • BS, RAC preferred
  • Work Hours: Hours will include the possibility of evening and weekend work

Education: Bachelor’s Degree

Salary: $90,000 – $110,000 USD /year