Associate Regulatory Affairs Manager

Job Title: Associate Regulatory Affairs Manager

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.
Find out more:
Our approach to R&D


Position Summary
You will support regulatory activities in Taiwan that enable safe and timely access to medicines. You will work closely with local and global colleagues, regulatory authorities, and cross-functional partners. Your work will include submission preparation, lifecycle maintenance, and regulatory intelligence. We value clear communicators who act with integrity, learn quickly, and focus on making a meaningful impact. This role offers growth, hands-on experience, and the chance to contribute to GSK’s mission of 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:

• Prepare and assemble regulatory submission dossiers and supporting documents for local authority filings.
• Manage post-approval lifecycle activities, including variations, renewals, and labeling updates.
• Maintain regulatory records and update regulatory systems to ensure accurate, audit-ready data.
• Monitor local regulation and guidance, assess impact, and share timely regulatory intelligence with stakeholders.
• Work with cross-functional teams including Quality, Supply, Medical and Commercial to deliver regulatory requirements.
• Support communications with Taiwan health authorities and follow up on questions or information requests.

Why You?

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 field.
• Minimum of 5 years’ working experience in related healthcare field, at least one year for regulatory affairs or a related function in the pharmaceutical or biotech industry.
• In charge oncology experienced is a plus
• Experience preparing or supporting regulatory dossiers and local submissions.
• Good working knowledge of Taiwan regulatory requirements and processes.
• Proficient written and spoken English and Mandarin.
• Strong attention to detail, organisation, and ability to meet deadlines.

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

• Master’s degree or professional certification in regulatory affairs.
• Experience with electronic regulatory systems such as Veeva Vault or other document management platforms.
• Familiarity with artwork/label change processes and submission workflows.
• Experience working in a matrixed or global organisation.
• Prior exposure to clinical trial submissions or investigational dossier activities.
• Strong stakeholder engagement skills and ability to influence across functions.

Working Arrangement
This role is hybrid, with regular on-site presence required in Taiwan. Specific on-site days will be agreed with your manager.

How to Apply
If this role excites you and you want to help bring important medicines to patients, we encourage you to apply. Please submit your CV and a brief note that explains why you are interested in this role and how your experience matches the requirements. We look forward to hearing from 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.

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