When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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:
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.
Education:
An advanced degree in natural or related life sciences (MS, PhD or MD, DVM)
