CMC Renewals Regulatory Manager

Site Name: Poznan Grunwaldzka, Cairo Boomerang, Warsaw Rzymowskiego 53
Posted Date: Oct 17 2025

Join Our Team as a CMC Renewals Regulatory Manager – Lead, Innovate, and Transform!

At GSK, our goal is nothing short of transforming healthcare by positively impacting the lives of 2.5 billion people by the end of the decade.

We're on the hunt for an innovative and dynamic CMC Renewals Regulatory Manager to join our License Maintenance CMC Renewals Team in Global Regulatory Affairs.

This isn’t just another job—it’s an opportunity to blend science, technology, and leadership to ensure that high-quality, life-saving medicines reach patients around the world.

With easy access to cutting-edge digital tools and a commitment to continuous process improvement, you will be at the forefront of regulatory excellence and digital transformation.

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What You’ll Be Doing

As our CMC Renewals Regulatory Manager, you will take charge of both the regulatory submission process and the transformation of our digital capabilities. Your key responsibilities include:

• Team Leadership & Development
• Manage and develop a diverse team of regulatory professionals, fostering a motivating and productive work environment.
• Oversee HR aspects—from recruitment and professional development to performance management.
• Act as a trusted point of escalation for your team, ensuring challenges are met with swift, effective solutions.
• Regulatory Excellence
• Lead the preparation, quality checking, and submission of complex Pharma and Vaccines CMC regulatory packages.
• Maintain the highest standards of compliance with ever-evolving global regulatory guidelines.
• Proactively identify and mitigate risks to guarantee timely project completion.
• Digital Transformation & Process Improvement
• Support the implementation of digital tools and technologies that streamline regulatory processes.
• Champion continuous process improvement initiatives, driving efficiency across all levels of the regulatory submissions.
• Collaborate with both internal and external stakeholders to drive standardization and innovation.
• Stakeholder Collaboration
• Build and nurture robust relationships with global partners, ensuring seamless communication in a matrix environment.
• Represent the regulatory function in strategic discussions, working across departments to achieve common goals.

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What We’re Looking For

To excel in this role, you should bring:

• Educational Background & Expertise
• A Bachelor’s degree (or higher) in a Scientific or Technical field.
• Proven expertise in regulatory affairs with a strong emphasis on CMC-related activities.
• Leadership & Digital Savvy
• Demonstrated experience managing or working with direct reports.
• A proactive approach to leveraging digital technologies to enhance team performance and process efficiency.
• Experience guiding teams through change with strong problem-solving and negotiation skills.
• Communication & Interpersonal Skills
• Fluent proficiency in English
• Exceptional interpersonal skills to drive collaboration and maintain strong stakeholder relationships.
• Multitasking & Adaptability
• Ability to independently manage multiple projects, navigating complex tasks and shifting priorities with a disciplined, logical work style.

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What’s In It For You

At GSK, we believe our people drive our success. As part of our team you will enjoy:

• Competitive Reward Package
• Attractive benefits including an annual bonus, recognition awards for outstanding performance, and holiday benefits.
• Comprehensive life insurance, private medical package (with preventive healthcare services), and pension plan.
• Career and Personal Growth
• Development opportunities through internal and external training platforms.
• A chance to build your digital skillset while managing significant regulatory submissions.
• Inclusive, Flexible Work Environment
• A modern office with creative spaces and flexible working arrangements (hybrid model: 2–3 days/week in the office).
• A friendly, supportive community that values diversity, ensures work-life balance, and flexible work solutions.

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Make an Impact With Us

This is your chance to lead with impact and redefine regulatory practices on a global stage. If you are driven by challenges, passionate about digital transformation, and excited to make a genuine difference in patient lives, then we want to hear from you.

Please note: For candidates applying through internal processes, ensure you inform your current manager about your application.

If you require any adjustments during the recruitment process, feel free to contact our Recruitment Team at pl.recruitment-adjustments@gsk.com.

Location:

• Flexible hybrid working model available at our modern office.

Apply today to be part of a team where you can lead, innovate, and transform the future of healthcare!

#LI-GSK #LI-HYBRID

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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