- Responsible for local regulatory submissions plan
- Contribute to development of regulatory strategies for new products and changes to existing products in line with business objectives
- Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities in the country
- Manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with relevant parties
- Manage compliance of product labels and liaise with supply chain for the implementation in commercial shipments in the country
- Life cycle management of existing product portfolio to ensure regulatory compliance and licence renewals to support business needs
- Provision of regulatory advice to regulatory colleagues in the region and other colleagues in the organization
- Collation of information from the region for periodic safety updates reports
- Responsible for all regulatory operations that involve liaising work within the company functions such as Production, R&D and QA departments as well as external agencies such as health authorities in the country.
- Manage company regulatory affairs activities including reports, license transfers and renewals to ensure compliance with government requirements and company standards
- Pharmacy, Science degree or equivalent
- 5-10 years relevant working experience in RA settings in the country, product registrations and life cycle management
- Pharma experience
- Medical device experience a plus
- Quality experience a plus
Join a company on the verge of tremendous growth in Southeast Asia. Become a key member of the company's structure and ambitious plans.
Michael Page