About the role

The Senior Regulatory Affairs Specialist is responsible for planning and executing all activities necessary for product registration and maintenance of product license, including change management and maintain good communication with all Cook manufacturing facilities and entities to obtain support wherever required.

Key responsibilities

• Write and review new product and change submission dossiers for Cook Medical's products in Thailand in accordance with authority and company requirements.

• Preparation and submission of additional licenses with Thai FDA such as License per Import and Special Access License.

• Negotiate with local authorities on behalf of Company objectives. Act as the key person to communicate and negotiate with local regulatory authorities.

• Understand and maintain database and systems used for regulatory controls and submission work.

• Create and maintain training materials to improve awareness on Thailand regulatory landscape for colleagues across Cook Medical manufacturing sites and entities where necessary.

• Keep up with Thailand regulatory requirements and inform relevant internal parties on a timely manner. Update Cook Medical manufacturers and key stake holders of any changes in local regulatory requirement and assist to ensure affected parties fully understand the changes and impact. Provide strategy or solutions to meet local regulatory requirements.

• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirement.

About you

• Degree in Science, Engineering or other related discipline.

• At least 3 years working experience in regulatory field for medical device or pharmaceutical industry would be an advantage, preferably in multinational companies.

• Experience in regulatory submission work and negotiation with regulatory authorities.

• Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.

• Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.

• Fluent in English and Thai (both spoken and written).

• Skilled in document management, able to multi-task and prioritize tasks.

• High level of computer skills including Microsoft Office.

• Positive attitude, open to changes, good team player, and attentive to details.