Regulatory Affairs Consultant

Title: Regulatory Affairs Consultant

Location: Taiwan – fully remote

Duration: 6- 12 month contract (possible extension)

Company Overview:

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

Responsibilities:

• Dossier Management: Lead the preparation, compilation, and submission of product registration dossiers and GMP registration documents for assigned projects.
• Lifecycle Maintenance: Manage the timely ordering of registration samples, clinical/technical dossiers, and essential certificates (CPP, FSC, etc.).
• Strategic Planning: Actively contribute to registration strategy discussions with both local and global teams to optimize timelines.
• TFDA Liaison: Track submission status within the TFDA, address technical inquiries, and manage product testing requirements with TFDA laboratories.

Qualifications:

• Bachelor's degree in pharmacy, Chemistry, Life Sciences, or a related field
• Minimum 3–5 years of experience in Regulatory Affairs within the Pharmaceutical industry in Taiwan.
• Strong biologics experience
• Proven experience in Taiwan GMP site accreditation (both Desk-top filing and on-site support).
• Proficiency in both Chinese and English (written and spoken) is mandatory for communicating with local authorities and global regional teams.

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, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process