CMC Regulatory Affairs Manager

United States, United States,

Posted:66 days ago
Location:United States, United States,
Job Ref:BH-31562
Job Type:Contract
Expiry date:2/2/2023
Contact:Callum Costello
This is an exciting long term contract working for a global pharmaceutical company in USA. This role can be done remotely or if you are based in New Jersey there is an option for you to go into the office. 


  • Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
  • Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers.
  • Serve as the CMC Product Lead for assigned products
  • Lead development and execution of global product and project regulatory strategies
  • Collaborate with client and external partners to support compliant execution of change management
  • Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
  • Bachelor's or master’s degree required in science, engineering or related field (advanced degree preferred).
  • Experience with CMC Submissions for FDA, EMA and RoW regions.
  • Marketing authorization/ CMC post approval experience
  • Proven Project Management experience

Apply now