Regulatory Affairs Manager

Description

• As part of the Global Product Stewardship team supporting the local and regional business units, you will provide regulatory and technical relations leadership to enable the launch of multiple innovation programs in Thailand market. This role involves close collaboration with Regional Regulatory, as well as R&D, QA, Marketing, and Supply Chain teams
• In this role, the candidate will:
• Lead the regulatory strategy for the launching new projects in Thailand.
• Demonstrate strong initiative to drive regulatory compliance, meeting business needs in a timely manner.
• Collaborate with regional regulatory managers, R&D and product supply function to lead regulatory compliance assessment of formulations, labels, and packaging
• Develop and implement regulatory strategies to ensure successful initiatives.
• Proactively identify and resolve opportunities/issues that could impact the regulatory compliance of our products.
• Collaborate with multi-functional teams to address technical challenges or issues raised by internal and external stakeholders.
• Build technical expertise in regulatory affairs across different product cenvironmentategories.
• Operationalize regulatory compliance work to improve efficiency and effectiveness.
• Support efforts to influence and shape a positive external regulatory

Job Qualifications

• A Bachelor's Degree or higher in Pharmaceutical Sciences or a related field is required.
• 1-3 years of experience working in the field of regulatory affairs is desirable. Candidates with experience in hazardous substance and medical device registration will have an advantage.
• Possess the ability to apply their academic background in science and technology to generate and interpret data, as well as solve problems effectively.
• Possess strong interpersonal skills and the ability to communicate effectively with stakeholders from different cultures and level, both internally and externally.
• Excellent problem-solving skills, attention to details and uses data to connect multiple ideas and develop solutions.
• Able to work independently, multi-task and perform in a high-pressure environment
• Fluency in the Thai language and strong verbal and written communication skills in English are required
• Proficiency in using Microsoft Office applications is necessary
• Have the ability to manage a team and demonstrate strong leadership qualities. This includes setting priorities, managing projects, and fostering cross-functional engagement to promote a positive team culture and enhance team capabilities