Experience - Manager, Regulatory Affairs filling into US and EU market.
JOB DESCRIPTION
1) Responsible for authoring, compilation and submission of dossier in US, EU, Canada, Australia, recent registrations and renewals.
2) Review of CMC documentation as per country specific requirements viz. productd development documents , Validations ( analytical method validation, media fills, process validation, hold time studies ), DMFs and related product documentation required for filing of registration dossiers in Stringent regulatory authorities.
3) Maintenance of Product life cycle tracker / MIS as per respective SOPs.
4) Handling of Product life cycle management activities viz. variations, renewals, notification, annual reports, PVG compliance submission.
5) To co-ordinate with cross functional team for documentation generation, review, and finalization.
6) Revi - Manager, Regulatory Affairsions, CAPA and interlinked QMS documents related to pre and post approval changes.
*Should have exposure to handle end to end activities for dossier filing for sterile dosage forms like ophthalmics, injectables.