Global Regulatory Affairs Manager, Vaccines

ENGINEERINGUK; London; On-site; GBP 60,000 - 100,000; Full time

Job description

Global Regulatory Affairs Manager, Vaccines

Site Name: Belgium-Wavre, Italy - Siena, Poznan Business Garden, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, Zug House, Zurich Schaerenmoosstrasse
Posted Date: Apr 2 2025

About the role

As a Manager, you will be responsible to the Global Regulatory Lead (GRL) for developing and implementing robust global and/or regional regulatory strategies for assigned vaccine assets.

About the responsibilities

• Lead regulatory strategy and submissions for WHO prequalification.
• Lead the regulatory interactions and ensure the timely implementation of the regulatory strategies for our global health projects.
• Collaborate extensively within GSK, including working with local and regional commercial teams.
• Proactively develop and implement the regulatory strategy that will deliver the needs of the local region(s), with a global mindset.
• Lead regulatory interactions with WHO and Health Authorities and the review processes.
• Ensure compliance with global/ regional requirements at all stages of the product lifecycle.

About you

Basic Qualifications & Skills:

• Bachelor's degree in Biological or Healthcare Science and 5 years of experience; or at least a master degree.
• A minimum of 6 years experience in the field of regulatory affairs.
• Experience in managing WHO Prequalification submissions and knowledge on WHO requirements to be able to work independently.
• Exposure to all phases of the drug development process in regulatory affairs, with a focus on clinical.
• Capable of leading development, submission, and approval activities in local region(s).
• Knowledge of the vaccines field and ability to further develop necessary specialist knowledge for the product portfolio.
• Ability to foster effective matrix working relationships and facilitate dialogue between the immediate team members and matrix team members to incorporate diverse ideas.
• Good communication and influencing skills.
• A proactive and flexible approach to the assigned responsibilities: a problem-solver who sets clear goals, prioritises tasks, anticipates challenges and takes initiative.

Preferred Qualifications & Skills:

• PhD degree in Biological or Healthcare Science.
• Has held previous positions that involved external facing interactions.
• Broad understanding of external regulatory landscape especially in emerging markets.
• Experience in developing and implementing regulatory strategies to support clinical development of vaccines and their licensure.
• Proficiency in digital fluency capabilities, including AI, to enhance project delivery and drive efficiency and innovation.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

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.