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Skills:

Product Development, Compliance, English

Job type:

Full-time

• 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.

Skills:

Product Development

Job type:

Full-time

• Develop and execute regulatory strategies for medical device products, ensuring alignment with business objectives and up-to-date regulatory trends.
• Identify regulatory requirements and potential challenges early in the product development process.
• Submission Management.
• Prepare, review, and submit high-quality regulatory documentation for submission to Thai FDA for new product registration and variation.
• Manage timelines and deliverables for regulatory submissions to ensure timely approvals.
• Compliance Oversight.
• Ensure that products comply with all local, national, and international regulations, guidelines, and standards throughout their lifecycle.
• Monitor and interpret changes in regulatory requirements and communicate their impacts to cross-functional teams.
• Regulatory Agency Interactions.
• Serve as the primary point of contact for regulatory agencies, facilitating clear communication and effective problem-solving during interactions.
• Prepare and lead presentations during agency meetings to address inquiries and advance regulatory submissions.
• Bachelor s degree in Life Sciences, Engineering, or a related field.
• Minimum of 2 years of experience in regulatory affairs within the medical device industry.
• Comprehensive understanding of global regulatory requirements in Thailand.
• Proven track record of successful submissions and approvals for medical device.