Sector: Health, Medical & Pharmaceutical
Our client is an independent pharmaceutical French group founded 70 years ago. Currently expanding its business internationally, the Group has decided to create a regional Hub in Hong Kong to support the growth in APAC.
- Prepare and implement the annual regional registration plan according to business need and dossier readiness.
- Develop and manage regulatory strategies to smooth products market access.
- Ensure portfolio’s regulatory compliance (variations, renewal, pricing etc…) in liaison with the corporate team.
- Be in direct contact with the local Health Authorities.
- Review and approve all packaging materials, marketing and training tools for the company’s portfolio.
- Coordinate the importation activities (batch analysis and custom clearances).
- Write and manage the Quality Management System in compliance with GMP, GDP and the Company guidelines.
- Implement and monitor the Quality Performance Indicators.
- Prepare the Management Quality Review.
- Build the annual audit plan and perform internal and external audits.
- Establish and ensure product quality complaints process in collaboration with the Group.
- Check all quality documents from subcontractors or service providers, propose corrective or preventive actions if necessary and coordinate follow-up in collaboration with the Group.
- Participate in Authorities inspections and ensure CAPA plans follow-up. Prepare training materials for procedures and organize the employees training.
- Manage projects for industrial transfer with our partners in the area Asia/ Pacific.
- Manage and coordinate the pharmacovigilance’s subcontractor according to the requirements given by Health Authorities.
Regulatory and competitive intelligence:
- Maintain an up to date regulatory, technologic, scientific awareness.
- Perform competitive surveillance.
- Act as the key contact person on regulatory topics for Asian & Pacific countries.
- Ensures timely, clear communications to internal stakeholders on project status and issues.
- Ensure data quality, reliability and archiving.
- 8 to 10 years of experience in Regulatory Affairs and Quality.
- PhD in Pharmacy or in Chemistry, Biology.
- Understanding of the overall pharmaceutical business.
- Knowledge in regulatory affairs in Asia and/ or Pacific.
- Good communictaion skills and ability to coordinate internal and external partners.
- Organized, rigorous, autonomous.
- Knowledge in the management of a Quality System.
- Proficiency in sales techniques (distribution channel).
- Fluent in English and Mandarin.
+852 2294 7710