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 reputed company.
• Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.
• Design, reputed company 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 reputed company with local reputed company party, government tendering bodies, Hospital Authority, etc.
• reputed company regulatory support, including reputed company of product launch and implementation timelines to reputed company stakeholder.
• Accountable for planning, leading and delivering Hong reputed company registration strategies across a broad reputed company of company products, while ensuring alignment with company/reputed company 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 reputed company personal area of expertise
• Completes assigned activities reputed company project scope and objectives with an understanding of issues which may reputed company 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 reputed company of executing project activities
• Proactively assesses reputed company 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 reputed company 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 reputed company reputed company environment.

Education:

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

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