รายละเอียดงาน
<Job responsibilities>
- Manage and mentor the Regulatory affairs team, providing guidance, support. Conducting performance evaluations and provide feedback to drive continuous improvement
- Develop and implement Regulatory strategies to ensure compliance with local and international regulations related to laboratory chemicals, glassware, and instruments.
- Oversee Regulatory compliance in warehouse operations, ensuring proper storage, handling, and delivery of chemicals and lab supplies
- Collaborate with the logistics team to establish and Maintain proper procedures for the transport of chemicals and sensitive lab equipment
- Work strategically with the Business Development team to provide Regulatory consultation
to customers, enhancing company's value proposition
- Develop and implement policies and procedures (P&P) for regulatory compliance across all departments
- Set strategic direction for the Regulatory Affairs department, aligning with commercial objectives and other departments' goals
- Develop and implement risk management strategies related to Regulatory compliance
- Stay up-to-date with changes in regulations and industry standards, and communicate these changes to relevant stakeholders
- Oversee the Preparation and submission of Regulatory documentation for chemical products and lab supplies to relevant authorities, ensuring accuracy and timeliness
- Ensure all Regulatory activities comply with applicable regulations and standards, including those Set by DIW, DID, DOA, FDA, and Other relevant Regulatory bodies.
- Collaborate with cross-functional teams (e.g., product, sales, Marketing, warehouse, logistics) to ensure Regulatory compliance throughout the product lifecycle and supply chain
- Conduct internal audits and inspections to ensure compliance with Regulatory requirements and company policies
- Liaise with Regulatory authorities, developing and maintaining effective working relationships, and represent the company in all Regulatory matters
- Provide training and Development opportunities to enhance the skills and knowledge of the Regulatory team and Other cross-functional teams
- Contribute to the Development of educational content related to chemical regulations and safety for our customers and the broader community
- Participate in industry associations and forums to Stay informed about Regulatory trends and best practices
- Oversee the management of in-house Regulatory files, documentation, and databases, ensuring compliance and that all records are kept up-to-date.
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