RA Specialist
Key Responsibilities
- Preparation and submission of regulatory dossier
- Able to deliver registration goals with minimum supervision
- Monitoring and follow-up of product filings for early approval of applications
- Revision of artworks including prescribing information to ensure regulatory compliance
- Product lifecycle management i.e. variations, renewals and post-approval commitments
- Participates in industry association to keep abreast of regulations
- Creation/revision of new/existing SOPs
- Management of quality activities i.e. product release, complaints handling, deviations, change controls self-inspection, trainings, documentations, risk management.
- Management of pharmacovigilance activities such as adverse event monitoring
- Audit of third party distributor
- Supports internal/external audits and implementation of corrective and preventive actions
- Able to develop and maintain good network internally and externally
- Performs other tasks and duties which may be assigned by the immediate supervisor from time to time
