Job Description
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 following job duties: Prepare, compile, review and finalize post-approval supplements (PAS, CBE30, 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 the 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: $80600.00 Per Year.Benefits: 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 LLC2 Tower Center Boulevard, Suite 1101A, East Brunswick, NJ 08816