Associate Director, Oncology Therapeutic Group

Site Name: UK – London – New Oxford Street, Baar Onyx, UK – Hertfordshire – Stevenage
Posted Date: Dec 3 2024

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.

As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data.

You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies.

In this role you will

1. Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
2. Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
3. Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data.
4. Lead interactions with local/regional regulatory authorities.
5. Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects.
6. Ensure compliance with global/regional requirements at all stages of the product life cycle.

Basic Qualifications & Skills:

• Bachelor’s degree in biological or healthcare science.
• Experience in the drug development process within regulatory affairs.
• Proven ability to manage development, submission, and approval activities in different regions globally.
• Ability to develop necessary specialist knowledge for the product in a specific oncology disease area.

Preferred Qualifications & Skills:

• Advanced Scientific Degree (PhD, MD, PharmD).
• Knowledge of all phases of the drug development process in regulatory affairs.
• Capability to lead regional development, submission, and approval activities in local region(s).
• Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally.
• Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.

Closing Date for Applications – 31 Jan 2025 (COB)

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. 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.

As an Equal Opportunity Employer, we are open to all talent.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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