Regulatory Affairs Consultant

Regulatory Affairs Consultant - Hong Kong

At Parexel, we are driven by a shared mission to improve global health. We achieve this by providing comprehensive clinical development solutions, from regulatory affairs and consulting to market access. Our work is fueled by a deep conviction in what we do, and each team member plays a vital role in bringing life-changing therapies to patients. We approach our work with empathy and a commitment to making a tangible difference.

About the Role

We are seeking a senior Regulatory Affairs Consultant to join our team in Hong Kong. This role is crucial in establishing and maintaining a high-performing group of regulatory affairs professionals, ensuring efficient and harmonized operations to support company objectives. You will collaborate closely with regional regulatory experts and manage external stakeholders, including government bodies and hospital authorities.

Key Responsibilities

• Lead and develop a team of regulatory affairs professionals to support company plans in Hong Kong.
• Collaborate with regional regulatory expertise on labelling and CMC aspects within Therapeutic Areas.
• Design, implement, and maintain processes for managing external stakeholders, including liaison with third parties and government tendering bodies.
• Provide regulatory support and oversight for product launches and implementation timelines to internal and external stakeholders.
• Develop and execute Hong Kong registration strategies for a diverse product portfolio, ensuring alignment with commercial strategies.
• Deliver technical and business consulting services within your area of expertise, adhering to Parexel's consulting models.
• Manage project scope and objectives, identifying and resolving technical and process issues in collaboration with colleagues.
• Proactively assess client needs and develop solutions to address challenges.
• Ensure client satisfaction through effective service delivery.
• Mentor junior staff and potentially deliver training.

Requirements

• At least 5 years of experience in the Hong Kong pharmaceutical industry; biologics regulatory experience is preferred.
• Proficiency in PRS2.0.
• Demonstrated experience in strategic leadership across the product development and commercialization lifecycle.
• Proven experience in building high-performing Regulatory Affairs teams and achieving objectives within a complex matrix environment.
• Advanced degree in natural or related life sciences (MS, PhD, MD, or DVM).
• Excellent teamwork and collaboration skills.
• Strong consulting skills.
• Exceptional interpersonal and intercultural communication skills, both written and verbal.
• Critical thinking and problem-solving abilities.
• Fluent in Cantonese and English.