DUTIES AND RESPONSIBILITIES

• Manage all activities related to Regulatory Affairs (pre-submission, submission, and life cycle maintenance).

• Ensure compliance of regulatory requirements, company & principals' policies.

• Handle the whole process of registration project for Drug products, Medical devices and Foods under FDA requirements and committed timeline.

• Classify the product to be complied with particular FDA's channels.

• Plan, coordinate and manage for lot release to be ready for sale on time.

• Prepare Certificate of Analysis translation for responsible products.

• Response to questions and/or comments from FDA authorities.

• Consult, review, and advise on promotional materials to be published under marketing and sales activities such as advertising, leaflets, sales promotion programs and all activities related to Regulatory Affairs.

• Support the team to ensure objective's meet.

• Ensure all regulatory information and guideline are up to date. Review new statement, circulate to concerned parties.

• Review all customer questionnaires/queries and ensure all answers meet company's policy and regulations within committed timeline.

• Update regulatory submission tracking record and prepare monthly registration status reports for responsible products.

• Providing support and expertise in area of healthcare product registration to internal stakeholder and principals as requested.

QUALIFICATION:

• Bachelor's degree in Pharmacy

• Minimum 7 years experiences in area of regulatory affairs for healthcare products

• Have knowledge on FDA rules and regulation

• Have knowledge on Pharmaceutical product license requirement

• Good command of Thai and English in writing, listening and speaking

• Good computer skill in Microsoft Word, Excel and PowerPoint

• Sense of urgency, ability to manage priorities under pressure and be able to multi-tasks

• Well-organized, self-driven with good communication, problem solving, hard-working, and reliable

• Proactive, assertive, and able to work independently and as team.