GSK

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 out of disease together. Find out more:

Our approach to R&D

Regulatory Lead

Are you ready to make a meaningful impact in regulatory affairs while advancing your career? In this role, you will play a key part in ensuring compliance with health authority regulations and supporting the delivery of regulatory submissions. You’ll collaborate with cross-functional teams, contribute to process improvements, and help maintain the lifecycle of products. We value candidates who are detail-oriented, proactive, and passionate about driving results. Join us to grow your skills, work on impactful projects, and help us achieve our mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilites:

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

• Develop and implement regulatory strategies to ensure timely submissions and approvals.
• Preparation and completion of regulatory submissions and approvals of NCEs (new chemical entities) within the defined timelines
• Execution of maintenance activities of the registered products including post-approval submissions (renewals, technical variations, new indication, label updates) and conduct effective cross-functional interactions to preserve business continuity
• Execution and follow up regulatory processes for both locally manufactured and imported products.
• Follow up CMC activities of locally manufactured products in collaboration with External Supply & Quality teams
• Follow up on the MoH correspondences.
• Participation to brand teams and giving input for regulatory activities and action plans.
• Execution of GMP related tasks including inspection submissions which require close follow up with internal and external stakeholders
• Monitor changes in local and global regulations and assess their impact on product registrations.
• Collaborate with cross-functional teams to ensure alignment and execution of regulatory plans.
• Build and maintain strong relationships with health authorities and external stakeholders.
• Identify risks and propose solutions to ensure business continuity and compliance.

Why you?

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in pharmacy, chemistry, or a related scientific field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of local regulatory requirements and processes.
• Proficiency in English (written and verbal).
• Good knowledge of MS Office tools
• Excellent organizational skills and attention to detail.
• Ability to work collaboratively in a team environment and adapt to dynamic situations.

Preferred Qualifications

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 and tools, such as Veeva Vault or similar platforms.
• Knowledge of global regulatory requirements, including EU and US markets.
• Strong interpersonal skills and ability to engage with senior stakeholders effectively.
• Demonstrated ability to identify process improvement opportunities and implement solutions.

This role is hybrid, requiring two days per week in the office.

If you’re ready to take the next step in your career and contribute to impactful work, we encourage you to apply today!

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.

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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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