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 lead CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines. You will work closely with colleagues across regulatory, quality, supply and project teams to prepare clear, compliant dossiers and respond to agency questions. We value people who are careful, curious and collaborative. This role offers strong growth, meaningful impact on patient access, and the chance to develop global regulatory expertise while helping GSK unite 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 CMC sections for regulatory dossiers, variations, renewals and responses to regulatory agency questions.
- Review technical data and ensure submissions are complete, accurate and ready for filing.
- Work with manufacturing, quality, supply and local regulatory teams to meet submission timelines.
- Monitor local regulatory changes and apply updates to dossiers and internal procedures.
- Identify regulatory risks, propose mitigation, and support change control and compliance activities.
- Contribute to process improvements, templates and publishing practices to increase quality and efficiency.

Why You?

Work arrangement
This role is based in the Philippines and follows a hybrid working model. You will spend regular time on-site and work remotely as agreed with your manager.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Biotechnology or a related technical field.
- Minimum 3 years’ experience in regulatory affairs or the pharmaceutical industry with exposure to CMC activities.
- Practical knowledge of CTD structure and experience preparing Module 3 content.
- Strong written and spoken English, with clear document writing skills.
- Good organisation skills and ability to manage multiple tasks to strict deadlines.
- Attention to detail and a commitment to high quality work.

Preferred Qualification
If you have the following characteristics, it would be a plus:
- Master’s degree or higher in a relevant scientific discipline.
- 3 to 5+ years’ experience with CMC submissions and post-approval variations.
- Experience with eCTD publishing tools or regulatory submission platforms.
- Knowledge of regulatory requirements in multiple international markets.
- Experience working in cross-functional, matrix teams within a global company.
- Prior experience mentoring or training junior colleagues.

What we value
You take ownership, deliver high-quality work and communicate clearly. You are curious and open to learning. You act with integrity and keep patient safety central. You help create an inclusive workplace where everyone can do their best work.

Ready to apply?
If this role matches your skills and ambitions, we encourage you to apply. Tell us about your CMC experience and how you collaborate with cross-functional teams. We look forward to learning how you can help bring high-quality products to patients.

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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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