Regulatory Affairs Specialist

Regulatory Affairs Specialist – Cronus Pharma

Join to apply for the Regulatory Affairs Specialist role at Cronus Pharma.

Regulatory Affairs Specialist needed w/ Master’s degree or Foreign Equivalent in Pharmaceutics or Drug Regulatory Affairs or Pharmacy and one (1) year experience as a Regulatory Affairs Specialist or Regulatory Affairs Associate performing the following job duties:

• Prepare, compile, review and finalize post-approval supplements (PAS, CBE
  30, CBE0 and Labeling supplements), deficiency responses/amendments and Annual Reports.
• Manage self‑identification, establishment registration, drug listings.
• Review and file submission documents for adverse event reports.
• Prepare and publish regulatory submissions as per FDA/ICH requirement.
• Interact with other functional departments during the entire R&D development process (review / submission / approval) to coordinate and facilitate quality and timely submissions.
• Create, revise and review labeling per current FDA requirements.
• Assist in FDA inspections.

Salary: $80,600.00 Per Year.

• PTO
• Health, Dental, Vision
• Basic life and AD&D
• Short term disability
• Long term disability
• Accidental death
• Cancer & specified illness

Job Location:

East Brunswick, NJ.

Mail resumes to:
Cronus Pharma LLC, 2 Tower Center Boulevard, Suite 1101A, East Brunswick, NJ 08816