Regulatory Affairs Manager
応募 後で応募 求人ID R0111097 掲載日 11/29/2023 Location:Taipei, TaiwanBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
OBJECTIVE:
To handle registration administration processes on the assigned project(s) of
responsibility in order to ensure product lifecycle management timely and properly
and comply with internal and external regulatory requirements.
ACCOUNTABILITIES:
1) To be responsible for regulatory submissions (NDA) for product
registration, line extension, product variation, post- market approval
change, license maintenance etc.
2) New plant master file (PMF) registration and maintenance in line
with requirements of local regulation.
3) Execute and lead the assigned project to ensure compliance with
domestic directives as well as government regulations.
4) Provide regulatory services to business unit to ensure early assess
of new products as well as hospital listing.
5) Handle toll manufacturing projects with related change in line with
government requirements.
6) To maintain current knowledge base of existing and emerging
regulations standards or guidance documents in order to update
company on new regulations/new procedures.
7) To prepare or maintain technical files as necessary in order to obtain
and sustain ethical product approval.
QUALIFICATIONS:
1. Degree in Medical/Science, pharmacist preferable
2. Familiar with pharma. regulation, at least 4+ years of RA experience in
multinational company / Pharma. industry.
3. Aggressive, independent, well organized, willing to work under pressure, good
communication, coordination and interpersonal skill, good command of English and local language
TRAVEL REQUIREMENTS:
Occasional local travel required (10%)