Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
2 Years
Description
- 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.
Qualifications
Highest qualification: University
- 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 regulationsHave 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