CMC Regulatory Affairs Manager

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. 

Responsibilities:

• 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

Qualifications:

• 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