Associate - Regulatory affairs
Associate - Regulatory affairs
Posted on :
23-07-2025
Employer Active
1 Vacancy
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Job Description
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
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
Employment Type
Full-time
Key Skills
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