Regulatory Affairs Manager - Thailand

About the client

Our client is a global sustainability leader offering Water, Hygiene & Infection Prevention solutions & services across more than 40 countries globally.

About the role

The Regulatory Affairs Professionals play a vital role in ensuring compliance with government regulations and industry standards. They are responsible for overseeing the regulatory process for products, from development to post-market approval. With the ever-changing landscape of regulations, finding the right person for this job is essential for the success and compliance of a company.

Roles & Responsibilities

As a Senior Regulatory Affairs Professional, you will play a crucial role in ensuring compliance with regulatory requirements and standards in the industry. Your responsibilities will include developing and implementing regulatory strategies, collaborating with cross-functional teams, and ensuring that products and processes meet all relevant regulatory guidelines.

This role requires strong attention to detail, exceptional communication skills, a deep understanding of regulatory processes and requirements, and most importantly, to possess the commercial mindset and business acumen to partner closely with the business to drive growth.

• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
• Leverage regulatory expertise with business acumen to partner closely with the business stakeholders to clear regulatory clearance for speed to market
• Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory
• requirements are incorporated into the development process.
• Monitor and track regulatory compliance metrics and provide regular reports to the leadership.
• Maintain a thorough understanding of international regulations in relevant markets and guide the organisation regarding international expansion plans.

Required Skills

• Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.
• Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage.
• Exceptional attention to detail and ability to review and interpret technical documentation, scientific data, and regulatory guidelines accurately.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to both technical and non-technical stakeholders.
• Strong project management skills and the ability to prioritize and manage multiple projects simultaneously.
• Proficient in using regulatory databases and software applications to track and manage regulatory submissions and documents.
• Strong analytical and problem-solving skills, with the ability to identify and resolve regulatory issues effectively.
• Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels.

Required Qualifications

• Bachelor's degree in a scientific discipline, engineering, or related field. Master's degree is preferred.
• Minimum of 8-10 solid years of experience in regulatory affairs within the relevant industry.
• Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products.
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, EU regulations, ISO standards, and other applicable regional regulations.
• Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
• A team player with care and collaborative persona
• Possessing strong business acumen and commercial mindset
• Strong understanding of quality systems and the ability to apply regulatory requirements to quality management processes.
• Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.