Role & responsibilities
Independent variation submission to UK
Artwork/PIQ/Safety Submission to EU/UK
Renewal submission to EU/UK
Sunset Exemption to EU/UK
Independent change control assessment
EU CTD dossier understanding/submission to EU/UK
Hands-on experience on Module 1 and Module 3 sections
Publishing of eCTD sequences
MRP/DCP Variation submission procedure
Launch product GAP analysis/impact assessment
Educational Qualification B.Pham/ M.Pham/ MSC
Any specific requirement Immediate joiner can be preferred. Launch product GAP
analysis/impact assessment can be helpful.
Interested candidates can share profiles on as****a@cr***********a.com
Keyskills: Regulatory Affairs life cycle management Safety Submission Regulated Market Post approval