Submission Lead, Submission Delivery Excellence, Lifecycle Management

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

Are you ready to make a meaningful impact in a dynamic regulatory role? As a Submission Lead in Submission Delivery Excellence, Lifecycle Management, you will play a key role in ensuring the timely and high-quality delivery of regulatory submissions. You'll collaborate with cross-functional teams to support the lifecycle management of pharmaceutical products, helping us get ahead of disease together. We value candidates who are detail-oriented, proactive, and skilled at building relationships across teams. This role offers opportunities for growth, learning, and contributing to a mission that improves lives worldwide.

Responsibilities

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

• Coordinate and deliver regulatory submissions, ensuring compliance with global and local requirements.
• Collaborate with cross-functional teams to compile and review submission packages, including Chemistry, Manufacturing, and Controls (CMC) documentation.
• Monitor regulatory changes and provide guidance to internal teams on evolving requirements.
• Support audits and inspections, ensuring adherence to regulatory and company standards.
• Identify opportunities for process improvements and contribute to optimizing regulatory workflows.
• Build and maintain strong relationships with internal and external stakeholders to ensure smooth regulatory processes.

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, biotechnology, or a related field.
• Strong understanding of regulatory submission requirements and lifecycle management processes.
• Excellent written and verbal communication skills in English.
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Attention to detail and commitment to delivering high-quality work.

Preferred Qualification

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

• Master's degree in regulatory affairs, pharmacy, or a related field.
• Experience working in a matrixed, international environment.
• Familiarity with regulatory systems such as Veeva Vault or similar platforms.
• Knowledge of global regulatory requirements, including EU and US markets.
• Strong interpersonal skills and ability to collaborate effectively across teams.
• Demonstrated ability to engage and influence senior stakeholders.

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- to discuss your needs.

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