เงื่อนไขการค้นหา

ทักษะ:

Product Development, Compliance, English

ประเภทงาน:

งานประจำ

• Develop and implement regulatory strategies aligned with business goals and current trends.
• Identify regulatory requirements and potential challenges early in product development.
• Submission Management.
• Prepare, review, and submit regulatory documentation to Thai FDA for product registration and variations.
• Manage submission timelines and deliverables to ensure timely approvals.
• Compliance Oversight.
• Ensure products meet local, national, and international regulations throughout their lifecycle.
• Monitor and communicate changes in regulatory requirements to relevant teams.
• Regulatory Agency Interactions.
• Act as the primary contact for regulatory agencies, ensuring clear communication and effective problem-solving.
• Lead presentations during agency meetings to address inquiries and progress submissions.
• University Degree in Pharmaceutical Science. Master Degree will be a plus.
• Proven track record in handling product registration with Thai FDA.
• Minimum 3-5 years experience in managing product registration processes in Pharmaceutical in a multinational environment.
• At least 3 years experience in Pharmaceutical Registration field is a plus.
• Have a strong connection with Thai FDA is a plus.
• Good understanding of regulatory compliance and strong knowledge of local regulatory requirements for product registration.
• Strong planning, organizing and analytical skills.
• Outstanding problem solving and decision making skills.
• A professional attitude and high ethical standards.
• Good networking skills and result-oriented.
• Excellent communication skills in both Thai and English (verbal and written).
• Good computer skills.

ทักษะ:

Contracts, Legal, Compliance, English

ประเภทงาน:

งานประจำ

• Draft, review, and negotiate contracts and legal documents in Thai, local languages, and English, ensuring alignment with business operations and legal requirements.
• Provide legal advice and consultation on various business activities, including advertising and product labeling.
• Ensure compliance with laws governing financial transactions, such as long-term loans and capital increases for subsidiaries.
• Conduct legal research, summarize findings, and report updates to management.
• Provide notarial services and legal document certification.
• Oversee the preparation and submission of corporate filings, such as board resolutions and changes in company structure.
• Manage business licenses and coordinate with external legal firms for necessary approvals.
• Liaise with subsidiaries and external law firms to ensure legal procedures are completed in a timely manner.
• Prepare reports and provide updates on relevant legal matters to senior management.
• Develop internal processes and documentation systems for better legal oversight.
• Perform other duties as assigned by management.
• Bachelor s or Master s Degree in Law or equivalent.
• Minimum of 8 years of relevant legal experience.
• Strong proficiency in Thai and English (both written and verbal).
• In-depth knowledge of business laws, international trade regulations, and stock exchange rules.
• Understanding of corporate governance and organizational projects.
• High level of responsibility and ability to learn new legal frameworks.
• Strong decision-making and problem-solving skills.
• Leadership ability to manage and guide the legal team.