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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%)

Locations

Taipei, Taiwan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time