Senior Director, Global Regulatory Lead

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 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.

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Our approach to R&D

Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile. 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 labeling to meet the Medicine Profile, commensurate with the available data.

Position may have direct reports.

Accountable to GRL (if not the GRL) and/or Global Regulatory TA Head for development of appropriate regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and including representing GSK with regulatory agencies as appropriate. Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the IAP and the Medicine Profile.

Once 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.

• Provides direct line management responsibility for TG staff
• Ability to attract talent, challenge and manage and develop direct reports
• Manage performance for direct reports (e.g. My Plan, Reward, Recognition, PIPs, etc.)
• Is an active contributor to the Therapeutic Group LT but also drives specific topics such as resource demands and workforce planning
• Understands well and is able to drive resource management conversations including new assignments, gap identifications, while taking into account individual’s needs
• Assist in managing TG budget

• Proactively develop a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Ensure implementation of the regulatory strategy(s) 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
• 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 IAP.
• Capable of providing critical regulatory assessment as part of due diligence/business development activities

Basic Qualification

• Bachelor’s degree in life sciences, pharmacy, medicine or a related discipline.
• Extensive experience (7+ years) of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
• Extensive knowledge of…