Regulatory Affairs Consultant

Key Accountabilities:

Main Responsibilities

• 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 company plans in Hong Kong.

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

• 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, etc.

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

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

• Other job duties that may be assigned from time to time.

Consulting Activities and Relationship Management

• Follows and implements the organization’s consulting models and methodologies

• Provides technical and/or business consulting services within personal area of expertise

• Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

• Collaborates with colleagues to identify and resolve technical and process issues

• Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities

• Proactively assesses client needs and develops processes and solutions to address issues

• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided

• Interactions result in clients expressing satisfaction with service provided

• May deliver training

• Mentor of junior staff

Skills:

• Teamwork and collaboration skills

• Consulting skills

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Fluent in Cantonese and English.

Knowledge and Experience:

• 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 commercialisation lifecycle with examples of contribution.

• Experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.

Education:

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