Senior Director, Global Regulatory Lead
Shpehouston, Jonesboro, AR, United States
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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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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