Regulatory Affairs Officer

About the role

The Regulatory Affairs Officer ensures that pharmaceutical products meet all applicable local and international regulatory requirements. This position involves managing product registrations, licences, and ongoing compliance with authorities such as the Food and Drug Administration.

Key responsibilities

• Prepare, submit, and maintain product registration dossiers and licences with regulatory agencies.
• Monitor changes in pharmaceutical regulations and FDA guidelines to guarantee continuous compliance.
• Coordinate with internal teams to gather required documentation and data for submissions.
• Maintain accurate records of all regulatory interactions and decisions.
• Provide regulatory guidance to product development and marketing teams.

Required profile

• Bachelor’s degree in Pharmacy and a valid PRC pharmacist licence.
• At least 13 years of experience in regulatory affairs (preferred).
• Strong knowledge of pharmaceutical regulations and FDA requirements.
• Excellent attention to detail, organizational, communication and coordination abilities.

Required skills

• Regulatory documentation
• Regulatory submission processes

What we offer

• Opportunity to work on high‑impact pharmaceutical products.
• Collaborative environment with cross‑functional teams.