Regulatory - Senior Scientist
About this position
Responsibilities
• Deliver a compliant Thailand Healthcare business.
• Collaborate with Thailand leadership team on broad business & organization matters.
• Lead local registration strategy and planning for base business & new product development to support business objectives and deliver timely approvals.
• Build and maintain robust network with regulatory authorities. Engage them in timely manner to ensure smooth approvals.
• To ensure a robust submission dossier meeting the most current requirements is prepared in a timely manner.
• Manage internal & external approval process of new pack materials, POSM and advertisement materials.
• Ensure all relevant regulatory systems and databases are maintained up to date.
• Actively participate in cross functional meetings or coordination meetings for projects regionally and globally.
• To stay updated with the upcoming changes in regulatory legislation and guidelines and define impact to business.
• Negotiate and take a lead in driving long term external advocacy in partnership with Government Relations and relevant industry associations.
Requirements
• Graduate with degree (Bachelors/Masters) in Pharmacy. Registered pharmacist is required.
• Having minimum 8 years experience in regulatory associated with Consumer Health products. Extended experience and knowledge with focus on OTC medicines and health supplements will be advantageous.
• Demonstrated experience dealing with and influencing related government agencies, i.e.: Thai FDA towards successful regulatory outcomes.
• Knowledge and experience in GMP, GDP regulations will be an advantage.
• Communication Skills - Able to clearly present information to non-technical leadership teams through the spoken word. Able to write and speak clearly and effectively in English to the team.
• Decision Making & Problem Solving - Able to take action in solving problems while exhibiting judgement and a realistic understanding of issues, able to use reason, even when dealing with emotional topics.
• Policy and Procedures - Able to relate to routine operations in a manner that is consistent with established policies and procedures.
• Analytical Skills - Able to use a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions.
• Proficient in English- both written and oral.
• Proficient in Computer systems.