Senior Director, GRS Oncology, Global Regulatory Affairs

GSK•Rockville, MD

20h•Hybrid

About The Position

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 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.

Requirements

Bachelor’s 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.

Nice To Haves

Advanced degree (Master’s 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.

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.
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.