Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Position Summary

You will support and deliver regulatory activities that help ensure product availability and compliance in Hong Kong and Macau. You will work with global submission teams, local regulatory contacts, technical operations and commercial partners. We value people who are organised, curious and collaborative. This role offers visible impact for patients, clear ownership, and strong opportunities to grow your regulatory career while uniting science, technology and talent to get ahead of disease together.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Support, prepare and submit regulatory dossiers and lifecycle maintenance documents for Hong Kong and Macau.

• Coordinate inputs from clinical, quality, manufacturing and commercial teams to complete submissions on time.

• Maintain submission trackers, version control and milestone plans for transparency and audit readiness.

• Respond to local regulatory authority questions and support meetings when required.

• Support license maintenance activities, renewals and post-approval changes.

• Manage artwork activities, ensuring compliance with systems and processes.

• Identify and suggest process improvements to increase efficiency and reduce risk.

Why You?

Work arrangement
This role is on-site in Hong Kong. You will work regularly from the office to collaborate with local colleagues and partners.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in pharmacy, life sciences, chemistry or a related discipline.

• 3-5 years’ experience in regulatory affairs within the pharmaceutical or healthcare industry to be qualified for listed position. Junior positions will be considered for less experienced candidates.

• Knowledge of Hong Kong and Macau regulatory requirements and practices.

• Strong written and verbal communication skills in English; Cantonese or Mandarin is an advantage.

• Good organisational skills with attention to detail and ability to manage competing priorities.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Master’s degree or professional qualification in a related discipline.

• Experience working in a matrix environment with global and local stakeholders.

• Experience influencing stakeholders and coaching junior colleagues.

• Background in biologics, oncology or complex therapeutic areas.

What we value in you
You make evidence-based decisions and raise issues early. You balance pace with rigour and focus on quality. You build strong working relationships and share learning. You bring a growth mindset and a willingness to coach others. You will help improve patient access through regulatory excellence.

Ready to apply?
If this role feels like the next step for you, please apply. We welcome applicants from all backgrounds and support inclusion. Tell us how you want to grow and how your skills will move important regulatory work forward. If you need adjustments during recruitment, please let us know and we will support you.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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