Regulatory Affairs Associate

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 2 years of experiences in area of regulatory affairs for drug and healthcare 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