เงื่อนไขการค้นหา

ทักษะ:

Product Development

ประเภทงาน:

งานประจำ

• 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.

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:

Negotiation, English

ประเภทงาน:

งานประจำ

• Ensure the product, label, and advertising complied with the regulation, company guidelines, and policies.
• Risk prevention on formulation and label screening.
• Support all necessary regulatory information to related function.
• Maintaining and secure the regulatory database.
• Keep update new regulation.
• Build up a relationship to run the business smoothly with the Food and Drug Administration (FDA), Thai Industrial Standards Institute (TISI), Ministry of Commerce, Office of Consumer Protection Board, Thai Customs, and Others.
• Support all RA projects.
• Bachelor degree up in Food Science, Pharmacy or related field.
• Minimum 10 years working experience in regulatory affairs area especially in food product.
• Strong interpersonal, negotiation, communication and presentation skills.
• Good command of written & spoken English including computer literacy.
• High ability to learn with good attitude.
• Ability to effectively manage projects and good human relation.
• CP AXTRA | Lotus's
• CP AXTRA Public Company Limited.
• Nawamin Office: Buengkum, Bangkok 10230, Thailand.
• By applying for this position, you consent to the collection, use and disclosure of your personal data to us, our recruitment firms and all relevant third parties for the purpose of processing your application for this job position (or any other suitable positions within Lotus's and its subsidiaries, if any). You understand and acknowledge that your personal data will be processed in accordance with the law and our policy. .