Position: Specialist, Regulatory Affairs

Reports to: Senior Regulatory Affairs Manager

Location: Hong Kong

The Company:

Your new organization is a leading pharmaceutical company committed to improving global health, focuses on discovering and delivering innovative medicines to address a wide range of medical challenges. With a diverse portfolio spanning immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, the firm strives to make a remarkable impact on people's lives.

Major Responsibilities:

• Manage variation applications in Hong Kong and Macau, ensuring alignment with company priorities.
• Prepare, review, and advise on regulatory submission documents for Hong Kong and Macau.
• Oversee the company's portfolios, including CMC variation, CCDS updates, label management, and product license maintenance.
• Serve as the primary liaison with commercial and brand teams, providing regulatory support for product life-cycle management.
• Collaborate with regulatory agencies to ensure timely reviews and approvals in accordance with company priorities.
• Update package inserts and finished product labelling to meet internal and external requirements.
• Review promotional and educational materials for compliance as needed.
• Maintain regulatory operation systems to facilitate efficient submissions and approvals.
• Manage product registration database for timely and accurate information transmission.
• Provide support for tender applications.
• Assist Managers in regulatory strategies, policy shaping activities, and ad-hoc projects.

What You Need

• Bachelor's degree or above in a science-related subject.
• Previous experience in regulatory affairs within the pharmaceutical or biotech industry preferred.
• Experience with multinational companies is advantageous.
• Familiarity with regulatory guidelines and requirements.
• Strong communication and project management skills.
• Fresh graduates or candidates without regulatory experience will be considered for the RA Associate position.

What you need to do now:

If you're passionate about making a difference in healthcare and possess the necessary skills and qualifications, we invite you to join our dynamic team committed to improving lives worldwide. Email your latest CV to Kalpana.charles@linksinternational.com