Job Overview

We are seeking a skilled Regulatory Affairs Consultant to join our dedicated team focused on advancing global health initiatives. In this pivotal role, you will be responsible for leading a group of high-performing regulatory affairs professionals, ensuring efficient collaboration and compliance with regulatory standards in Hong Kong.

Responsibilities

• Establish and maintain a team of regulatory affairs professionals to support company objectives in a productive manner.
• Collaborate closely with regional regulatory experts across various therapeutic areas, focusing on labelling and Chemistry, Manufacturing, and Controls (CMC).
• Design, implement, and sustain processes or systems to manage external stakeholders, including local change implementation management.
• Engage with local third parties, government tendering bodies, and other stakeholders to facilitate document provision and regulatory compliance.
• Monitor regulatory changes and ensure the team adapts strategies accordingly to meet evolving requirements.
• Support the development of regulatory submissions and maintain a robust compliance framework.
• Provide training and mentorship to junior team members, fostering a culture of continuous improvement and knowledge sharing.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs, preferably in the healthcare or pharmaceutical sector.
• Strong knowledge of regional and international regulatory requirements and guidelines.
• Proven ability to lead and manage cross-functional teams effectively.
• Excellent communication and interpersonal skills, with the ability to build relationships with stakeholders at all levels.
• Detail-oriented with strong analytical and problem-solving skills.
• Fluency in English; proficiency in Cantonese or Mandarin is an advantage.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and career advancement.
• Work in a collaborative and supportive environment committed to making a difference in global health.
• Flexible working arrangements to promote work-life balance.