Senior Regulatory Specialist, New Registration CMC, CMC Excellence

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

Senior Regulatory Specialist, New Registration CMC, CMC Excellence

The CMC Regulatory Affairs group at GSK is located across multiple sites and plays a crucial role in ensuring the approval and continuous supply of medicines. Within the CMC RA group, the New Registrations CMC team bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers and CTA submissions. The New Registrations CMC team provide regulatory support across for development and registration of new pharmaceutical, biopharm and vaccines products.

Your Responsibilities :

• Managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products including response to questions from Agency;
• Define and agree regulatory strategy, complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements;
• Effective communication also in a digital context, including virtual meetings and digital platforms;
• Act as subject matter expert in regulatory processes;
• Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems;
• Supporting digital transformation through active participation in building digital skills;

Why you?

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

Why GSK?

At GSK we offer a wide range of additional benefits :

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As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment- to discuss your needs.

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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