- As assigned, gather, analyse and communicate internal and external regulatory intelligence
- Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
- Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with guidance from DRA Management
- As assigned, represent Affiliate Regulatory in cross-functional teams
- Adapt global product dossiers to local requirements
- Prepare and manage regulatory registration filings across product lifecycles: Communication with global for filing, submission & requirements(CPP, ToC, Bridging report, GMP inspection & documents, Sample)
- Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
- Ensure timely regulatory filings submissions and approvals
- Influence internal and external stakeholders for successful regulatory outcomes
- Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
- Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
- Ensure regulatory compliance for product released to market according to marketing authorisations
- Ensure that all the changes (CDS, TRIC) for responsible products are proceeded according to local SOP and avoid the non-compliance
- Timely manage HA request within defined timeframe by HA : Renewal, Re-evaluation, Safety instruction, Patent, Orphan Renewal, Barcode registration
- Timely inform the relevant stakeholders of the approval
- Ensure the Regulatory Affairs database is updated with regulatory activities, timelines and priorities as per the Regulatory Standards and ensure accuracy of the data (GPRS, Local Tracking logs)
- Bachelor degree, or above majored in pharmacy. (Pharmacist is preferred.)
- Total 3~8 years of experience and minimum 2 years of experience in RA of pharmaceutical company.
- Knowledge of Pharmaceutical Affairs law and MFDS regulation.
- Demonstrated excellence in documentation.
- Good at communication, English and computer skill