Manager, Global Regulatory Affairs, Oncology

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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Are you a driven and motivated regulatory affairs professional? As a Global Regulatory Affairs Manager at GSK, you will play a pivotal role in developing and executing global and regional regulatory strategies for our assets. Your efforts will ensure that our development programs meet the needs of key markets and align with the Medicines Profile. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head, ensuring timely submission and approval of clinical trial applications.

In this role you will

• Regulatory Strategy: Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
• Cross-functional Collaboration: Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
• Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
• Regulatory Intelligence: Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Minimum of a Bachelor's degree in biological or healthcare science.
• Minimum of 1 year experience in the drug development process within regulatory affairs.
• Proven ability to manage development, submission, and approval activities in different regions globally.
• Knowledge of clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.
• Capacity to develop specialist knowledge for products in specific oncology disease areas.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced Scientific Degree (PhD, MD, PharmD).
• Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Ability to develop networks within GSK to secure support and achieve project outcomes.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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