Regulatory Specialist, SDE- Investigational

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

This role supports regulatory management by ensuring alignment between GSK’s business objectives, strategy, and the necessary processes to meet Health Authority requirements for regulatory submissions. The Regulatory Operations Specialist will contribute to the optimization and continuous improvement of GSK’s regulatory systems and processes.

The Specialist will collaborate with stakeholders to support the prioritization and implementation of global regulatory submissions, ensuring both compliance with Health Authority requirements and alignment with GSK’s business goals. This includes execution of project timelines and maintaining communication with stakeholders.

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

Contribute to the preparation of Clinical Trial Application (CTA) packages for EU and Non-EU regions, including Application forms and Market Specific documents, and compiling submission components (e.g., Investigator’s Brochure (IB), protocol, Investigational Medicinal Product Dossier (IMPD), etc.).

Support the preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN), and EU Study Summary submissions.

Collaborate with project teams to assist in the planning and compilation of Development Safety Update Reports (DSURs), new US Investigational New Drug applications (INDs), and IND amendments.

Follow Regulatory System processes precisely and consistently, ensuring alignment with Global Regulatory Affairs (GRA) Standard Operating Procedures (SOPs), Work Instructions, and How-to Guides.

Maintain a patient-focused mindset while learning to identify opportunities for process efficiency and simplification.

Advocate for and support the use of Regulatory Systems among stakeholders and submission deliverable providers.

Partnering with peer colleagues in Submission Delivery Excellence and the Regulatory Asset Oversight team to maximize resources and to identify and remove barriers that will prevent a successful outcome on submission delivery targets.

Maintaining awareness of emerging investigational regulatory requirements across regions in scope of role.

related role in the pharmaceutical or clinical research environment.

• Has knowledge of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to global submission requirements.
• Good knowledge of relevant regulations and standards relating to the submission of regulatory applications and drug development worldwide.
• Ability to coordinate the submission delivery activities as an integral member of a Regulatory Operational team.
• Ability to work well both independently and within a team to ensure on-time delivery of objectives/projects.
• Ability to work with and add value to matrix teams in a globally diverse organization.

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 IN.recruitment-adjustments@gsk.com to discuss your needs.

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