Regulatory Affairs Manager, Thailand

Core Mission:

• Provide strategic regulatory guidance to the Thailand leadership team, aligning functional
• strategies with business objectives.
• Deliver project goals and ensure regulatory operations support business growth.
• Lead and manage local regulatory operations, securing necessary approvals for new products, manufacturing permits, and import permits in Thailand.
• Develop and execute regulatory strategies, defining priorities aligned with business objectives
• and embedding functional capabilities to drive growth.
• Ensure compliance with existing licenses, timely approval of marketing authorizations, and provide regulatory input on new product development.
• Serve as the primary liaison with government regulators, maintaining effective relation-
• ships and shaping the regulatory environment.
• Strengthen local regulatory capability through training, coaching and mentoring the team as well as providing guidance to global RA team in order to increase their understanding of regulatory requirements in Thailand.

Responsivities:

• Develop and execute regulatory strategies to support local business objectives, ensuring proactive regulatory advice and input on feasibility, requirements, and timelines.
• Prepare and submit high quality regulatory affairs applications, including new product registrations, variations, and geographical extensions, across various product classes. Facilitate aspects of these applications, including submission, responses to questions, and negotiations with the Health Authority.
• Perform regulatory maintenance of registered products, ensuring compliance with applicable requirements and updating product packaging and associated information timely as well as ensure that product licenses are updated in line with Company Core Safety Information according to global requirements.
• Implement and maintain local regulatory procedures, ensuring compliance with global regulatory affairs standards and SOPs.
• Review and approve promotional and non-promotional materials, ensuring compliance with local regulations, code of conduct, and internal guidelines.
• Communicate progress of applications and changes to registered details to local and global stakeholders in a timely manner.
• Develop and manage effective working relationships with Health Authorities, business units, and other stakeholders.
• Stay up to date on relevant regulatory, industry, legislative, and competitor activities to develop effective regulatory strategies for the company product portfolio.
• Support the launch of new products by collaborating with cross-functional teams.
• Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority with the aim of attaining the most competitive product labels (whilst maintaining ethical standards) and the earliest possible commercial launch.
• Manage in-house regulatory files, documentation, and databases (RIMS), ensuring accuracy, completeness, and compliance.

Others:

• Lead, coach, retain, develop and motivate team member(s) within the regulatory affairs
• function.
• Foster and maintain good cross-functional working relationships with other departments.
• Represent the company in the relevant committees of the professional/industry associations, if necessary.
• Perform any other duties related to Regulatory Affairs.

Requirements:

• Education/Training: University degree (BSc or Master) in pharmacy and a licensed pharmacist

by the Pharmacy Council of Thailand

Work Experience:

• Minimum 8 years working experience in the regulatory affairs field within an international environment.
• Good working knowledge of medicines, medical devices and cosmetics registration procedures and regulatory aspects in Thailand.

Language:

• Proficiency in written and spoken English.

Required pre-requisites skills/experience for this position:

• A good understanding of the commercial drivers of the healthcare industry and an associated ability to provide advice/guidance that takes these into consideration.
• Analytical skills and attention to detail with the capability to appropriately define issues,
• questions and data.
• Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the HA, Industry Associations and internal
• stakeholders.
• Skills such as project management, problem-solving, ability to present information in an easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills.
• Ability to work both independently or as part of a team as required.
• Be proactive, motivated and a self-starter.
• Be able to balance company commercial needs with compliance requirements.
• Ability to think strategically and innovatively for resolution of regulatory issues.
• Commitment to continued improvement in department processes and performance.
• Strong team player, assisting others with workload peaks and the management of challenging situations.
• Proactively contributes to a positive team attitude and highly productive work environment.