United States, United States,
|Posted:||66 days ago|
|Location:||United States, United States,|
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