1 year ago by Classic Search
International Regulatory Affairs
Job Description
- experience in IRA handling APAC regiona submissions, handling a team of 2 for submission
- Good understanding experience in handling APAC markets.
- Evaluation and Regulatory Impact Assessment of Change Controls and Deviations.
- Understanding and awareness of Asia Pacific region Pharma regulations with country specific requirements, checklists guideline on latest regulations
- Assumes Accountability on Deliverables
- Ability to contribute to Plan and execute Dossier Compilation
- Ensure timely Review and Submission to Health Authorities of assigned APAC Markets
- Planning and Submission of Amendments / Supplements
Classic Search
