Senior Director, Global Regulatory Lead

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. The position may have direct reports.

Key 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 this role, planning will be on a multiple year horizon, 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.

When a Team Leader

• Provides direct line management responsibility for TG staff
• Attracts talent, challenges, manages and develops direct reports
• Manages performance for direct reports (e.g., My Plan, Reward, Recognition, PIPs, etc.)
• Contributes to the Therapeutic Group LT and drives specific topics such as resource demands and workforce planning
• Conducts resource management conversations including new assignments and gap identification while considering individual's needs
• Assists in managing TG budget

When a GRL

• Proactively develops a regulatory strategy focused on the key markets identified, promoting innovative regulatory approaches when beneficial
• Assesses precedent, regulatory intelligence and competitive environment from a regulatory perspective and their impact on the regulatory strategy for an asset
• Leads regulatory interactions and the regulatory review processes
• Ensures effective interaction with local regulatory counterparts in priority markets and global commercial teams
• Ensures compliance with regulatory requirements at all stages of product life
• Advocates persuasively to senior leaders in GSK and health authorities
• Provides broad development input/expertise to other core members of the MDT and/or EDT beyond regulatory input
• Acts as single point of accountability on the EDT/MDT, leads the Regulatory Matrix Team, and delivers the Regulatory Work Package(s) associated with the IAP
• Capable of providing critical regulatory assessment as part of due diligence/business development activities

Basic Qualifications

• 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 developing product/therapeutic knowledge in new areas
• Proven experience of leading development, submission and approval activities including organizing and executing successful milestone meetings and a successful relationship with one or more Health Authorities
• Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally; ideally proven experience of leading regulatory activities outside the local region

Preferred Qualifications

• 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

Working Model

This role is based in Belgium/UK/Italy or US. The working model is hybrid, combining on‑site collaboration with flexible remote work as agreed with the manager.

Benefits

• Annual base salary ranges $221,925 to $369,875 for U.S. locations (Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA)
• Annual bonus opportunities and eligibility for a share‑based long‑term incentive program dependent on role level
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays, vacation, paid caregiver/parental and medical leave

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