associate - regulatory affairs

Preparation of the required documentation for submission to the relevant regulatory
authorities and thorough follow-up
 Monitor and follow up the regulatory application submission status, including variations and
renewals.
 Support to manage regulatory inspection (as applicable) and Product life cycle maintenance
of all currently registered product licenses and maintain validity of all regulatory certifications
according to local regulation.
 Monitor local regulatory surveillance and perform impact assessment.
 Ensure regulatory compliance and proactively identify regulatory trends, manage new
implementation and communicate potential impacts to the manager.
 Adhere strictly the timelines in global procedure for submitting and verifying registration
information/data in global regulatory database.
 Support the preparation of technical documentation / dossier for hospital enlisting, tender
application, pricing submission, custom clearance, as applicable.
 Support the review of the product artworks
 Support all pharmacovigilance activities

experience

3