Responsible to establish and maintain a group of high performing regulatory affairs professionals.
Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.
Design, deploy and maintain processes to manage external stakeholders.
Provide regulatory support, including oversight of product launch and implementation timelines.
Accountable for planning, leading and delivering Hong Kong registration strategies across a broad range of company products.

at least 5 years of experience in the Hong Kong pharmaceutical industry;
biologics regulatory experience preferred.
Proficiency in PRS2.0
Experience of strategic leadership across product development and commercialization lifecycle with examples of contribution.
Experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.
Fluent in Cantonese and English.

Regulatory Affairs Consultant

Key skills