Job Description
Regulatory Affairs Assistance Manager/Manager (45K–65K) (SDG-112475) ผู้จัดการ/ผู้ช่วยฝ่ายกิจการกำกับดูแล 1 คน <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.
Job Requirement
<Necessary Skill / Experience > - Thai nationality , Male, Female , age 30 - 40 years old - Bachelor's degree - Bachelor's degree in a relevant field such as Chemistry, Chemical Engineering, Biology, Environmental Science, Public Health, or Business Administration with a focus on Regulatory Affairs. Advanced degree is a plus. - Minimum of 7 years of experience in regulatory affairs within the chemical, pharmaceutical, laboratory supply, or related industrial - Experience in developing policies and procedures for Regulatory compliance - Fluency in English (both written and spoken) - Proven Experience managing a team of Regulatory professionals - In-depth knowledge of Thai and international regulations related to laboratory chemicals, glassware, and equipment (DIW, DID, DOA, FDA, etc.) - Experience with warehouse and logistics regulations for chemical storage and transportation - Strong analytical and problem-solving skills - Excellent Communication and interpersonal skills - Strategic thinking and ability to align Regulatory functions with Business objectives - Ability to work in a fast-paced environment and Manage multiple projects simultaneously <Preferable Skills/Experience> - Certification in Specialist undertaking in hazardous substances from department of Industrial work - Experience in the distribution or supply chain of laboratory chemicals and equipment Language Skill English level : Conversational Japanese level : None Workplace Area: MRT Phetchaburi Working Hour: 8:00-17:40(Mon-Fri) About the Benefits 45,000–65,000THB About the company Product & Service: Trading Finish Goods of Fine Chemical & Analytical Reagents Business Type: General Trading Company;General Chemicals;