(Sr) RA Specialist
On-site · Taipei, Taiwan, Taiwan
Taipei, Taiwan, TaiwanOn-siteFull TimeSenior LevelNot SpecifiedUnknown
Type
Full Time
Level
Senior Level
Education
Not Specified
Company size
Unknown
Job Summary
Senior Regulatory Affairs Specialist in Taiwan focused on drug registrations. Coordinates regulatory strategies and submits regulatory documents (NDA, PMF, DMF, license renewals, variations) to authorities, ensuring compliance with FDA, EMA, and Taiwan FDA. Collaborates with R&D, QA, PV, manufacturing, BU and marketing; evaluates regulations and guides labeling/advertising to meet regulatory standards.
Required Qualifications
- Expert knowledge of drug regulations
- Good communication and problem-solving skills
- Excellent time management and project management skills
- Ability to collaborate with cross-functions
- Pharmacists are preferred
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