Job Title: Regulatory Subject Matter Expert (SME)
Location: Taiwan
Work Model: Fully Remote
Contract Period: 12 Month
Company Overview:
Apsida Life Science has partnered with a leading global Clinical Research Organisation (CRO) renowned for its scientifically driven programs. They specialise in managing complex Phase IIV trials across diverse therapeutic areas for innovative biotechnology and pharmaceutical firms worldwide.
The Opportunity
- Leading the preparation and submission of product and GMP registration dossiers for all assigned projects to ensure seamless market entry.
- Taking total ownership over regulatory milestones by tracking status within the TFDA, addressing technical inquiries, and managing lab product testing requirements.
- Executing Taiwan GMP site accreditation through expert desk-top filing, renewal management, and providing hands-on support for on-site inspections.
- Ensure all promotional materials, labelling, and internal activities align with TFDA standards and company SOPs.
- Partnering with global and regional teams to contextualise complex GMP practices for SMEs and providing regulatory guidance to internal departments.
What you need
- A Bachelor's degree or higher in Pharmacy, Pharmacology, Biology, Chemistry, or a related Life Science discipline.
- 4 + years of hands-on experience in Regulatory Affairs.
- Experience in Taiwan GMP site accreditation, including desk-top filing, renewals, and on-site inspection support.
- Experience preparing and submitting registration dossiers, ordering samples, and managing certificates
- Fluency in Chinese and English
What You Will Get:
- Total ownership over your country's clinical sites and regulatory milestones.
- A long-term 12+ month contract
- Work life balance
- Innovation
If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science:
[Confidential Information]
www.apsida.co.uk
+44 (0) 744 134 2145
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry.
