Regulatory Affairs Supervisor (Registered Pharmacist)
發佈於： 2026/3/17
Taipei Northern Taiwan
Permanent
生命科學、醫療保健、製藥
Responsibility
- Manage registration for company products (imported and manufactured), including new applications, license renewals, and amendment filings.
- Assist with compliance management and document review for GMP and GDP standards regarding domestic and international pharmaceutical manufacturers.
- Evaluate and provide feedback on technical data related to company products.
- Responsible for communication and coordination with domestic and international regulatory authorities; track updates to relevant laws and regulations.
- Assist in resolving regulatory or technical issues between domestic and international entities.
- Support supervisors with ad-hoc tasks or specialized projects (e.g., establishing timelines for pre- and post-market product launches).
- Compile promotional materials and plan/execute internal and external education and training programs for company products.
- Collaborate with the sales team to interact with customers (including, but not limited to, supporting consumer service hotlines) to understand needs and identify product application opportunities.
- Provide technical support and problem-solving advice regarding product applications to enhance customer satisfaction.
- Assist in collecting and evaluating data on competitor products.
- Participate in and execute company project tasks.
- Minimum of 3 years of experience as a Regulatory Affairs (RA) professional within the pharmaceutical industry.
- Must hold a valid Pharmacist License and willing to serve as the registered pharmacist of record for product licenses.
- Competency: High level of readiness with the ability to work independently