หน้าที่ความรับผิดชอบ

• Responsible and accountable for all regulatory activities in assigned products, including but not limited to the followings: o drug product licensing: new registration, post-approval maintenance, management of all variation’s promotional material internal review, submission, and approval from Thai FDA
• Ensure AE reporting to Thai FDA including the SMP protocol and unconditional approval of new drugs
• Work closely with Head of RA to plan and execute regulatory strategies for assigned products and projects in alignment of these with business plans and strategies supporting business expansion, brand value.
• Interact with relevant health authorities and other government institutions as needed to program responsible projects
• Ensure products remain compliant with all relevant regulatory and corporate requirements throughout their product life cycle especially labelling compliance and promotional materials review and approval. Contribute to development and implementation of standards and enable compliant practices and processes.
• Partner with relevant internal functional and cross-functional stakeholders (local, region, global), in delivering project outcomes aligned with desired business direction.
• Ensure maintenance of required licenses for proper operating of the company including certificates for medical devices.