Director, Global Regulatory Affairs Lead (Oncology)

The role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may also involve individual support for projects as a regional director or GRL.  The role reports directly to the GRS TG Portfolio Lead.  The Regulatory Director/Team Leader along with the respective Portfolio lead is responsible for:

• Provision of adequate resources to support the various development programs within the respective portfolio.
• Ensuring the development and effective execution of regulatory strategies for assigned assets. These strategies must be aligned with the Medicines Development Strategy and the Integrated Evidence Strategic (IES), ensuring that the development program fulfills the requirements of key markets as identified and the Medicine Profile.

All regulatory activities and line management must be carried out in strict compliance with internal GSK processes and policies, as well as with applicable regulatory requirements.

Leadership Responsibilities include but are not limited to:

Management of direct reports.

This requires mentoring/coaching of Team members, guidance to ensure successful implementation of regulatory strategies and adherence to all relevant internal and external standards and practices. 

The position may also involve individual support for projects as a regional director or GRL.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Accountable to GRS TG Portfolio Lead and TG VP for development of appropriate regulatory strategy(s) and for delivery according to plans.  In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to the TG VP level.  Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile. Resourcing includes recruitment of new staff. Work closely with the Portfolio Lead to develop coach/mentor individuals within the team including performance assessment/management. May also be responsible as a regional director or GRL for select asset(s)

When a Team Lead (as applicable):

• 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.)
• 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 individuals’ needs.
• Assist in managing TG budget.

When a GRL(as applicable):

• Works 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, works 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 strategy and 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, 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.

When a Regional Director (as applicable)

• Accountable to GRL and/or Portfolio Lead and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strateg