Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Regulatory Affairs Consultant
Primary Location: Hong Kong, Remote ID de la oferta R0000038615 Categoría Regulatory Affairs Fecha de publicación 03/02/2026
Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
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)
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Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
