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
The Regulatory Associate Manager III is responsible for ensuring timely delivery of regulatory activities across multiple projects and dosage forms, meeting submission timelines and quality standards. Acting as the New Registration CMC representative on Regulatory Networks and Matrix Teams, the role provides regulatory guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ), and the Office of the Chief Medical Officer (OCMO) to enable preparation of appropriate components for global dossiers. The post-holder mentors and trains new team members to support their development and integration into regulatory workstreams. They also serve as a Subject Matter Expert for specific CMC/regulatory areas, offering consultation and expertise both within the department and to external stakeholders.

Responsibilities

• Independently develop and execute agreed dossier strategy to meet regulatory and business objectives.

• Manage multiple projects simultaneously, handling varying complexity and delivering outcomes on time.

• Conduct thorough data assessments to ensure dossiers are complete, accurate and fit-for-purpose.

• Identify, document and mitigate risks related to submission data and information packages.

• Escalate critical issues to line management when they have business impact and support resolution.

• Review peers’ dossiers, recommend improvements, and contribute to enhancements of Regulatory processes, policies and systems.

• Act as subject-matter expert on applicable regulations, guidelines and procedures for product registration and manufacturing; provide consultation, training and mentoring to colleagues.

• Build and maintain stakeholder relationships across GSK and externally, share knowledge, and communicate effectively to support project and policy objectives.

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, pharmaceutical sciences or a related technical discipline.

• Minimum 5 years of regulatory affairs experience with a focus on CMC for small molecule products.

• Practical experience preparing and managing CTD Module 2 and 3 documentation or equivalent quality dossiers.

• Strong project management skills and ability to manage multiple regulatory submissions simultaneously.

• Good written and spoken English with the ability to draft, review and present regulatory content clearly.

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

• Proven track record responding to health authority questions and supporting inspection readiness activities.

• Experience working in a matrix environment with supply chain, manufacturing and commercial teams.

• Familiarity with comparability assessments, change control and stability data interpretation.

• Experience mentoring colleagues.

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

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