Regulatory Project Manager At GSK

Posted Date: Aug 1 2025

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.

About the Team:

We prepare the CMC sections of dossiers for Product Renewals across Rx, Bx, and Vx portfolios, ensuring compliance with regulatory expectations for EU and Rest of World markets. Our scope includes responding to Health Authority questions, supporting tenders, and managing site renewals while adapting to evolving market needs. Collaborating closely with Product Owners, manufacturing sites, and Local Operating Companies, we focus on delivering high-quality submissions efficiently and on time.

Operating in a global, diverse environment with team members in Poland, India, and Egypt, we value international collaboration as a key to success. As part of our digital transformation, we’re implementing tools to enhance data handling, submission tracking, and agility in cross-functional processes.

Key Responsibilities:

• Support and lead continuous improvement initiatives to streamline regulatory processes and enhance operational efficiency.
• Actively contribute to the implementation and optimization of digital tools and systems to improve data handling, submission tracking, and collaboration.
• Demonstrate ownership and initiative in driving cross-functional projects and process enhancements within a global team environment.
• Develop and manage regulatory submission plans for CMC Renewals Team deliverables, ensuring timely and accurate delivery.
• Collaborate with internal teams to gather, review, and prepare submission-ready documents.
• Ensure submissions meet global regulatory requirements and company standards.
• Monitor regulatory timelines and communicate updates to stakeholders.
• Identify and address potential risks to submission timelines or compliance.
  
  

Why You?

Basic Requirements:

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Experience in regulatory affairs, CMC, or pharmaceutical development.
• Demonstrated digital fluency—comfortable working with regulatory systems, data platforms, and digital tools to drive efficiency and compliance.
• Demonstrated ability to independently manage complex regulatory projects, proactively initiate and lead cross-functional initiatives.
• Strong interpersonal and communication skills for cross-functional collaboration.
• Proficiency in English (written and spoken).
  
  

Preferred Requirements:

• Master’s degree in life sciences or regulatory affairs certification.
• Experience with regulatory submissions for lifecycle management or post-approval changes.
• Familiarity with change management processes and regulatory strategies.
• Previous experience working in a global or matrixed environment.
  
  

Why GSK?

What we offer:

• Career with purpose – whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
• Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
• Hybrid working model ( 2/3 days per week in the office).
• Career at one of the leading global healthcare companies.
• Supportive & friendly working environment.
• Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.
  
  

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (pl.recruitment-adjustments@gsk.com) to further discuss this today.

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