Regulatory Affairs Pharmacist
BioNet-Asia
- อำเภอพระนครศรีอยุธยา, จังหวัดพระนครศรีอยุธยา
- งานประจำ
- ฟูลไทม์
- Provide and keep track of regulatory requirements of relevant activities on vaccine development process and licensing.
- Prepare and manage dossier of pre-marketing and post-marketing filing and submission until obtaining market authorization of a product.
- Maintain regulatory compliance.
- Update stakeholders of relevant changes in regulations and prepare action plans to comply with the regulations.
- Minimum of 2-3 years of experience in Regulatory Affairs and pharmaceutical industry.
- Bachelors' Degree in a Pharmacy.
- Fully fluent spoken and written English.
- A keen interest in vaccinology.
- Demonstrates knowledge of Thai FDA, eCTD and international regulatory requirements and process, content and guidelines according to GMP, GDP, GLP, and GCP.
- Ability to multitask and deliver on multiple projects.
- Ability to work well independently as well as part of a team.
- Good communication and problem solving skills.
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