Regulatory Affairs Consultant

Regulatory Affairs & GMP Compliance Specialist

Location: Taiwan (fully remote)

Duration: 12-month (full-time attendance)

Company Overview

Apsida Life Science is currently partnering with A global healthcare organisation that operates across pharmaceuticals, medical devices, and consumer health, with a long-standing presence in research, development, manufacturing, and commercialisation of innovative health solutions.

Responsibilities

• Responsible for product and GMP registration dossier preparation and submission of assigned projects.
• Responsible for timely ordering of registration sample, dossier, certificates, etc.
• Contribute to the discussion of the registration plan with both the local and global team.
• Track the registration status in TFDA and timely report to the line manager.
• Address technical questions from TFDA.
• Review of promotional materials and labelling.
• Experience in TW GMP site accreditation (I) desk-top filing and renewal, and (II) on-site inspection support
• Proficient in Chinese and English
• Thorough understanding of TW GMP regulation and practices, contextualised for SMEs

Qualifications:

• Bachelor's degree in pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum 35 years of experience in Regulatory Affairs within the Pharmaceutical or Medical Device industry in Taiwan.
• Proven experience in Taiwan GMP site accreditation (both Desk-top filing and on-site support).
• Proficiency in navigating the TFDA electronic submission systems.

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

[Confidential Information]

www.apsida.co.uk | +44 (0) 744 134 2281

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. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process