Regulatory Affairs Officer

Job Title: Regulatory Officer

Location: Keelung Road, Taipei City

Work model: Hybrid

Requirement: Submissions in Taiwan and attendance at the Health Authority office for submissions Contract Period: 1 Year - FTE

Company Overview:

Apsida Life Science has partnered with a global leader in clinical trial support services. This organisation is dedicated to making clinical trials more accessible by bringing research support directly to the site, ensuring that life-changing medicines reach patients faster.

The Opportunity:

• Regulatory Officer responsible for performing day-to-day submissions in Taiwan.
• Managing the submission of hard-copy and electronic documents to the TFDA.
• Compiling the Common Technical Document (CTD).
• Ensuring trial protocols are approved by local Institutional Review Boards (IRB).

What you need:

• Ability to perform day-to-day regulatory submissions in Taiwan.
• Ensuring all documentation and processes align with the standards set by the Taiwan Food and Drug Administration (TFDA).
• Willingness to attend Health Authority (HA) offices as needed for physical submissions.

What You Will Get:

• A competitive hourly rate
• A stable 1-year full-time contract.
• Negotiable in-office attendance.

If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science:

Email: [Confidential Information]

Website: www.apsida.co.uk

Phone: +44 (0) 744 134 2145