Our client is a global animal health company that has been in business for more than 50 years. The companydelivers quality medicines, complemented by diagnostic products and genetic tests that are supported by a range of services. Now they are looking for energetic candidates to join the team as its Regulatory Affairs Assistant Manager.
- Preparing registration dossiers according to FDA requirements and documents for various amendments of commercial products.
- Ensuring that all key products are submitted followinga strategic plan.
- Managing Thai FDA comments along the submission process and ensuringthat the company’s products obtain registration approval within timeline.
- Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.
- Ensuring regulatory compliance for all products with the current laws and regulations.
- Supporting product importation by ensuring that all documents are aligned with local requirements.
- Arranging and updatingregistered products’ packaging artwork.
- Performing other duties as assigned by supervisor.
- Male or female, age not over 35 years old.
- Bachelor’s or Master’s Degree in Pharmaceutical Science.
- At least 3 years experience in regulatory affairs.
- Responsible, hard-working and well-organized.
- Good command of English, both writing and speaking.
- Good interpersonal, negotiation, decision-making and problem solvingskills.