Senior Director, GRS Oncology, Global Regulatory Affairs

Business Introduction
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 peoples 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. Were uniting science technology and talent to get ahead of disease together.

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Our approach to R&D

Position Summary
Ensure the development of appropriate regulatory strategies and execution for assigned asset(s) consistent with Medicines Development Strategies/ Integrated Evidence Strategies to ensure the development program(s) meets the needs of the key markets identified and the Medicine Profile(s). This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labelling to meet the Medicine Profile(s) commensurate with the available data. This position may have direct and indirect reports serving as GRLs or in supporting roles but may also have direct GRL responsibilities for one or more select assets.

Key Responsibilities
Accountable to the Global Regulatory Strategy TG Head and/or Portfolio Lead for oversight of the development of appropriate regulatory strategies and delivery according to plans.

As a GRL you will:

• Work with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program. If prioritized by the MDT work closely with the global commercial team and local regulatory teams in prioritized countries to secure the best possible labelling commensurate with available data and in line with the GDS.
• Proactively develop regulatory strategies and promote innovative regulatory approaches when they benefit advancement of a given program. Ensure implementation of the regulatory strategies in support of the project priorities.
• Assess precedent regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
• Lead regulatory interactions and the regulatory review processes.
• Ensure effective interaction with local regulatory counterparts in priority markets and global commercial teams as applicable.
• Ensure compliance with regulatory requirements at all stages of product life.
• Advocate persuasively to senior leaders in GSK and in Health Authorities.
• Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
• Act as single point of accountability on the EDT/MDT lead the Regulatory Matrix Team and deliver the required Regulatory Work Package(s) associated with the IES.
• Capable of providing critical regulatory assessment as part of due diligence/business development activities.

Why You

We are seeking senior professionals who want to join a collaborative team focused on delivering patient impact. This role is located in the United States. The working arrangement is hybrid with expectation to be on-site for key meetings and leadership activities.

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

• Bachelors degree in a biological life science or healthcare field.
• Significant experience in regulatory affairs (10 years)
• 5 years experience across all phases of drug development and regulatory submissions.
• Track record leading global or regional regulatory strategy and interactions with health authorities.
• Experience working in complex matrix teams with clinical CMC commercial and safety functions.
• Strong written and verbal communication skills with ability to present clearly to senior leaders and regulators.

Preferred Qualifications
If you have the following characteristics it would be a plus:

• Advanced degree (Masters or PhD) in a relevant scientific or healthcare discipline.
• Direct experience leading regulatory filings and approvals across multiple regions.
• Extensive experience of all phases of the drug development process in regulatory affairs including for projects with little or no precedence.
• Knowledge and experience in Oncology TA preferably with ADC and lung experience
• Proven experience of leading development submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority.
• Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally. Ideally proven experience of leading regulatory activities outside local region.

How to apply
If this role speaks to your experience and goals we encourage you to apply. Share your CV and a brief note about what motivates you to join and contribute to our mission. We look forward to hearing from you.

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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 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 were 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.

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