Director, Global Regulatory Affairs Lead (Oncology)

GSK•Durham, NC

1d•$171,750 - $286,250•Hybrid

About The Position

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.

Requirements

Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry. (The source calls for extensive regulatory experience across all phases of development).
Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
Experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.

Nice To Haves

Advanced degree (PhD, MD, PharmD, or relevant master’s degree) in biology, Life Sciences, Healthcare Sciences.
Experience in resource management and forecasting.
Experience in all phases of the drug development process in regulatory affairs, including projects where there is little or no precedence.
Knowledge of relevant therapeutic areas or proven track record of being able to develop product.
Knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally.
Ideally, proven experience of leading regulatory activities outside local region.
Experience as a Global Regulatory Lead or equivalent leadership role.

Responsibilities

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)
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.
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.
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 strategy(ies).
In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.
Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data.
Lead interactions with local / regional regulatory authorities.
Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally
Implement the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with regional commercial teams in local region
Ensure compliance with regional requirements at all stages of product life from C2MD
Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
Capable of providing critical regulatory assessment as part of due diligence/business development activities.
Consistent ability to foster strong matrix working.
Proven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions.
Supports team members to appreciate how their ideas can be combined in order to create value for the whole group.
Ability to manage cultural diversity and be effective in leading global teams.
Ability to lead change and communicate difficult messages.
Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more.
Ensures implementation of longer-term plans or delivery of large scale projects.
Proven ability to build strong personal networks, both within and outside GSK and use them to secure appropriate support and outcome for a project.
Demonstrate a constant focus on improving performance and excellence in all tasks.
Challenges and questions ways of working to seek improved process.
Adds value through quantitative goal setting and provision of feedback to raise collective performance.
Delivers all communication with clarity, impact and passion, tailored to the audience.
Commands attention and interest through the use of a range of communication techniques and styles.
Makes complex ideas simple.
Is able to effectively interact across all levels and areas within the company.
Good listening and comprehension skills; ability to adapt personal style to a given audience; takes ownership and is productive in addressing potential problems before they become an issue.
Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations.
Capable of synthesizing complex information globally to ensure appropriate assessment of the “big picture” for a project.
Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints.
Strong overall business acumen.
Understands the needs of other functions.
Understands the competitive landscape in the commercial and pre-commercial space.
Ability to influence and manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options.
Builds and maintains an external network in order to help shape the external environment in collaboration with regulatory policy and other stakeholders.
Where appropriate, recognized internally and externally as an expert broadly, or in specific areas of regulatory strategy.
Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
Strong overall development and clinical/scientific acumen.
Good understanding of the diseases being addressed and the Medicines being developed.
Awareness/familiarity with the role of digitalization in development and regulatory strategy to enhance decision-making, and drive efficiency and innovation.
Clear understanding of the importance of following all applicable laws and regulations and role modeling GSK expectations and values.