Position Purpose: This position serves to provide operational support in Hong Kong regulatory management. This includes, but not limited to, defining and executing aligned regulatory strategies for new and existing products, including all developmental and lifecycle phases for all the company’s products in the market across commercial and domestic (Toll) portfolios.

Main Responsibilities and Accountabilities:

1 - Responsible to establish and maintain a group of high performing regulatory affairs professionals working in an efficient, productive and harmonized fashion to support the execution of the company’s plans in Hong Kong.

2 - Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.

3 - Design, deploy and maintain processes and/ or systems to manage external stakeholders, of which includes local change implementation management. External stakeholders include, but not limited to, provision of documents and liaison with local third party, government tendering bodies, Hospital Authority, Hong Kong Red Cross Blood Transfusion Service.

4 - Provide regulatory support, including oversight of product launch and implementation timelines to internal and external stakeholder.

5 - Accountable for planning, leading and delivering Hong Kong registration strategies across a broad range of the company’s products, while ensuring alignment with company/commercial strategies

6 - And other job duties that may be assigned from time to time.

Job Qualifications and Experience Requirements:

Education

An advanced degree in natural or related life sciences (MS, PhD or MD, DVM)

Experience

5 years of experience in the Hong Kong pharmaceutical industry; biologics regulatory experience preferred.

Competencies

Demonstrated experience of strategic leadership across product development and commercialisation lifecycle with examples of contribution. Demonstrated experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.

Lanugauges

Fluent in Cantonese and English.

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Regulatory Affairs Consultant