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
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
- 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