Overview

Manager, Regulatory Affairs Job at Hurley Consulting Associates – Summit, NJ

Job Details

Full-timeEstimated: $61,000 – $89,000 a year2 hours ago

Benefits

  • Life insurance
  • Health insurance
  • 401(k)

Qualifications

  • FDA regulations
  • Communication skills
  • Bachelor’s degree

Full Job Description

Hurley Consulting Associates, Ltd. is seeking a Regulatory Affairs professional to join our Regulatory Affairs group. Bachelor’s degree, preferably in the sciences or advanced degree with at least 3-5 years pharmaceutical industry in the preparation of INDs, NDAs, or BLAs. The Manager of Regulatory Affairs is required to have excellent written and oral communication skills and knowledge of FDA, ICH, and EMA guidelines.

The responsibilities include:

Preparation of regulatory submissions including INDs and IND amendments

Assist in the preparation of NDAs and BLAs

Preparation and management of submission compilation plans

Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance and 401(k) plan and support for RAC certification.

Job Type: Full-time

Education:

About the Company

Company: Hurley Consulting Associates –

Company Location:  Summit, NJ

Estimated Salary:

About Hurley Consulting Associates -