Senior Director, Global Regulatory Lead

GSK•Rockville, MD

22h•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 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.

Requirements

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 relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area.
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.

Nice To Haves

Advanced degree (Master’s, PharmD, MD or PhD) in a life science or related field.
Deep knowledge of clinical development, CMC and regulatory requirements across major markets.
Track record of successful global submissions and positive interactions with multiple regulatory agencies.
Previous line management responsibilities
Experience building or scaling regulatory teams and developing talent.
Experience in lifecycle management, variations and post-approval commitments.
Fluency in additional European languages, such as French or Dutch.

Responsibilities

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.
When a team leader 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