Regulatory Affairs Consultant

This is a fully remote position, open to applicants in Hong Kong.

📋 Description

• Tasked with establishing and sustaining a team of high-performing regulatory affairs professionals.

• Engage in close collaboration with regional regulatory specialists in the Therapeutic Areas regarding both labeling and CMC components.

• Create, implement, and uphold processes to effectively manage external stakeholders.

• Offer regulatory assistance, including supervision of product launch and execution timelines.

• Responsible for planning, directing, and executing registration strategies for Hong Kong across a diverse array of company products.

⛳️ Requirements

• Minimum of 5 years of experience within the Hong Kong pharmaceutical sector;

• Preference for candidates with biologics regulatory experience.

• Proficient in PRS2.0.

• Demonstrated experience in strategic leadership throughout the product development and commercialization lifecycle, with concrete examples of contributions.

• Proven track record in building high-performing RA teams and effectively achieving objectives in a complex matrix environment.

• Fluent in both Cantonese and English.

🏝️ Benefits

• Health insurance

• Professional development opportunities