Writing of renewal dossiers of products manufactured in Indian CMO’s and exported to Russia, Ukraine, other CIS countries, Sri Lanka, Nepal, Latin American countries and other countries (if any addition) etc.
Writing and review of new product dossiers/ renewal dossiers for products manufactured at CMO’s based in South Korea, Thailand and Philippines for export markets.
Maintenance of the entire renewal dossier and new product dossiers for Indian CMO’s and overseas CMO’s.
Preparation and submission of post approval variations and send proper communication for implementation of the change.
Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.
Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change
Updation of eTOC and dispatches dossiers through Veeva Vault.
Maintenance and distribution of Normative document to the responsible quality manager.
Implementation and follow GRA processes for all export product dossier management.
Life cycle management for all the products managed by EM India.
Qualification & Experience
B.Pharm/ M.Pharm/ MSc in lifesciences
Experience: (8-12 years of experience in Regulatory Affairs, Quality Assurance)