Responsibilities

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

• Ensure compliance of regulatory requirements, company & principles policies.

• Handle the whole process of registration project of Drug Products, Medical Devices, Foods and Cosmetic under FDA requirements and committed timeline.

• Classify the product to be complied with particular Thai FDA Channels.

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

• Prepare Certificates 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 meets.

• 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.

• Management of Pharmacovigilance activities as back up for responsible products carried out within Thailand according to principal and FDA regulations.

• 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 steak holder and principles as requested.

Qualification

• Bachelor's degree in Pharmacy or relevant fields.

• Minimum 1 years of experiences in area of regulatory affairs for drug and healthcare or medical device products.

• Have knowledge on FDA rules and regulations

• Have knowledge on Pharmaceutical & Healthcare products registration requirements and maintenance of licenses.

• Experiences in registering Oncology, Biological products, New Generics and Biosimilars will be an advantage.

• Fluency in English.

• Growth mindset