Regulatory Affairs Manager

Job Description

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Job Description

OBJECTIVE:To handle registration administration processes on the assigned project(s) ofresponsibility in order to ensure product lifecycle management timely and properlyand comply with internal and external regulatory requirements.ACCOUNTABILITIES:1) To be responsible for regulatory submissions (NDA) for productregistration, line extension, product variation, post- market approvalchange, license maintenance etc.2) New plant master file (PMF) registration and maintenance in linewith requirements of local regulation.3) Execute and lead the assigned project to ensure compliance withdomestic directives as well as government regulations.4) Provide regulatory services to business unit to ensure early assessof new products as well as hospital listing.5) Handle toll manufacturing projects with related change in line withgovernment requirements.6) To maintain current knowledge base of existing and emergingregulations standards or guidance documents in order to updatecompany on new regulations/new procedures.7) To prepare or maintain technical files as necessary in order to obtainand sustain ethical product approval.QUALIFICATIONS:1. Degree in Medical/Science, pharmacist preferable2. Familiar with pharma. regulation, at least 4+ years of RA experience inmultinational company / Pharma. industry.3. Aggressive, independent, well organized, willing to work under pressure, goodcommunication, coordination and interpersonal skill, good command of English and local languageTRAVEL REQUIREMENTS:Occasional local travel required (10%)

Locations

Taipei, Taiwan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time