Regulatory Affairs Manager - Thailand
Regulatory Affairs Manager - Thailand
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Job Description
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
- Bachelors degree in a scientific discipline engineering or related field. Masters 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.
Employment Type
Full Time
