Job Title Associate Regulatory Affairs Manager応募 後で応募 求人ID R0011881 掲載日 09/03/2019 Location:Taipei, Taiwan
- To responsible for regulatory submissions (NDA) for product registration, line extension, product variation, post- market approval change, license maintenance etc.
- New plant master file (PMF) registration and maintenance in line with requirements of local regulation.
- Execute and lead the assigned project to ensure compliance with domestic directives as well as government regulations.
- Provide regulatory services to business unit to ensure early assess of new products as well as hospital listing.
- Handle toll manufacturing projects with related change in line with government requirements.
- To maintain current knowledge base of existing and emerging regulations standards or guidance documents in order to update company on new regulations/new procedures.
- To prepare or maintain technical files as necessary in order to obtain and sustain ethical product approval.
- Degree in Medical/Science, pharmacist preferable
- Familiar with pharma. regulation, at least 4+ years of RA experience in multinational company / Pharma. industry.
- Aggressive, independent, well organized, willing to work under pressure, good communication, coordination and interpersonal skill, good command of English