Job Openings
Senior Regulatory Affairs Manager (Pharmacist)
About the job Senior Regulatory Affairs Manager (Pharmacist)
- Oversee all product registration-related tasks for pharmaceuticals, over-the-counter medications (OTC), medical devices, cosmetics, foods, chemicals, and biologics for ethical and other categories.
- Examine and assess the product documentation, and coordinate the production of any extra paperwork, clarifications, samples, etc. that may be needed for product registration.
- Ensure that all submissions and approvals adhere to Thailand's laws, principles, rules, and customs.
- Take the initiative in local government affairs activities by developing close relationships with government agencies in order to influence and respond pro-actively to the development of laws and regulations governing product registrations.
- Communicate the approved information &/or any changes to the concerned departments within/outside the company.
- Offer feedback and early warning of potential regulatory and quality problems, and suggest/develop preventative and corrective solutions by looking into registration options.
- Keep up with changing and new laws, rules, and the regulatory industry's broader competitive landscape to maintain a high degree of regulatory intelligence.
- Ensure documentation of the registered products
- Manage and coordinate all pharmacovigilance efforts for the drugs in accordance with Thai FDA rules
- Train and mentor team members to achieve established goals and objectives
- Lead the team to successfully deliver prioritized objectives that concentrate on the crucial activities on time and to standard.