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.
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Our approach to R&D


Position Summary

The Regulatory Submission Specialist, Submission Delivery Excellence (SDE), Lifecycle Management (LCM) works closely with global submission teams and Local Operating Company (LOC) regulatory contacts to deliver end‑to‑end regulatory submissions in line with agreed timelines. This includes the coordination and preparation of LOC Market‑Specific Requirements (MSRs), including MSRs developed and maintained in Spanish, in compliance with Regulatory Authority regulations and guidelines, and in accordance with GSK ways of working.

This role offers an excellent opportunity to further develop expertise in Regulatory Affairs while collaborating with cross‑functional teams and gaining exposure to global submission and lifecycle management activities.

The Regulatory Submission Specialist, Submission Delivery Excellence (SDE), Lifecycle Management (LCM) works closely with global submission teams and Local Operating Company (LOC) regulatory contacts to deliver end‑to‑end regulatory submissions in line with agreed timelines. This includes the coordination and preparation of LOC Market‑Specific Requirements (MSRs), including MSRs developed and maintained in Spanish, in compliance with Regulatory Authority regulations and guidelines, and in accordance with GSK ways of working.

This role offers an excellent opportunity to further develop expertise in Regulatory Affairs while collaborating with cross‑functional teams and gaining exposure to global submission and lifecycle management activities.

Key Responsibilities

• Lead end-to-end delivery of marketing applications and lifecycle maintenance submissions (renewals, variations, site registrations) in compliance with Regulatory Authority requirements, internal SOPs, and agreed timelines.
• Coordinate, author, and review Local Operating Company (LOC) Market-Specific Requirements (MSRs) — including documentation in Spanish — ensuring alignment with global dossier strategy and local regulatory expectations.
• Execute and support regulatory submission strategies across multiple scenarios, independently managing dossier planning, documentation readiness, and cross-functional inputs.
• Identify, assess, and proactively escalate submission-related risks with potential business impact, implementing mitigation plans to protect timelines and approvals.
• Apply regulatory guidelines, policies, and pharmaceutical manufacturing/registration requirements to ensure high-quality, compliant submissions.
• Lead or co-lead multidisciplinary discussions related to submission content, resource planning, timelines, lifecycle management, and continuous process improvement initiatives.

Qualifications

We are looking for professionals with the following qualifications and skills:

• Degree in a biological, healthcare, or scientific discipline (or equivalent experience in Regulatory Affairs).
• Solid understanding of pharmaceutical development, R&D processes, product registration, and lifecycle management.
• Proven ability to interpret and apply regulatory frameworks and translate requirements into compliant submission strategies.
• Fluency in Spanish (written and spoken) with experience preparing and reviewing regulatory documentation and MSRs in Spanish; strong professional communication skills in English.
• Experience working in global, matrix environments, effectively engaging cross-functional teams and management levels.
• Strong organizational skills, attention to detail, risk-based thinking, and ability to manage shifting priorities while delivering high-quality outputs on time.

How to apply
If this role feels like the next step for your career, please apply. We read every application and encourage you to include concrete examples of your submission work and system experience. We look forward to hearing from you and exploring how you can help us get ahead of disease together.

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.

If you require any type of accommodation and/or support during the selection process to better showcase your abilities (for example, access to ramps, accessible emergency exits, visual aids, etc.), please let us know when we contact you. We are here to support you.

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