หน้าที่ความรับผิดชอบ

As a Senior Manager – Scientific & Regulatory Affairs, your key tasks are as below:

• Manage all activities related to product registration for pharmaceutical products, chemical & biologics for ethical, OTC, medical device, cosmetic, foods and other categories.
• Review and evaluate the product documentation along with coordination for any additional documents, clarifications, samples, etc. as required for product registration.
• Make sure that all submissions/approvals comply with the laws, guidelines, regulations and practices in Thailand
• Communicate the approved information &/or any changes to the concerned departments within/outside the company
• Take initiative in local government affairs activities by cultivating close relationships with government agencies in order to influence and respond proactively to the development of laws and regulations governing product registrations.
• Provide input and advance notification on potential regulatory & quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations.
• Maintain a high level of regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain.
• Manage and coordinate all Pharmacovigilance activities for the products according to Thai FDA regulations
• Ensure documentation of the registered products
• Develop and coach team members to meet goals and objectives set
• Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and on quality