The Sr. Manager/Associate Director, Regulatory Asset Oversight will partner with the GRL and Regulatory Matrix Teams (RMT) and Early/Medicine Development Teams to provide over-arching project management support to active Rx and Vx projects across the lifecycle of the asset. Create and manage integrated regulatory plans, for purposes of operationalizing the Global Regulatory Strategy (GRS), and ensure team is on track to deliver per the Regulatory strategy. Facilitate the running of the RMT and acting as conduit for the GRL to the wider regulatory organisation and through their extended network engage with key partners outside of regulatory. Will be responsible for ensuring a consistent approach to Regulatory Asset oversight activities within and across project teams which best serve R&D Pipeline and key Established Products goals and ultimately the Patient. Responsible for promoting an agile and forward-looking culture which utilizes innovative technologies and techniques to develop comprehensive workplans which align with acceleration, efficiency, and compliance objectives. Collaborates and networks across the R&D matrix to ensure that project management and submission oversight activities are agreed and aligned to efficiently support R&D portfolio aspirations. Coordinates with Submission Delivery Excellence colleagues on the operational execution of the strategy. This role requires leadership within and across enterprise matrix teams including GRA (both central and at the Local Operating Company level), GRO, and contributing departments (e.g. Clinical Operations, Data Management, Stats and Programming) as needed to facilitate submission delivery expectations.

The job holder may be responsible for managing other Regulatory Asset Oversight Managers.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan,

• Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise.

• Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.

• Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.

• Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.

• Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.

• Proactively identifies upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to the Director, Regulatory Asset Oversight, and leadership.

• Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets.

• Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function.

• Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose.

• Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion. Job Description

• Serve as SME inputting to WoWs in conjunction with Stakeholders with a focus on continuous improvement, identification and implementation of automation opportunities, and compliance with Regulatory authority requirements.

• Maintains a network amongst GRA and R&D colleagues for awareness of best practices and identification of future opportunities.

Why you?

Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment

• Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

• Strong project management expertise in the pharmaceutical industry or in a regulatory environment, overseeing and prioritizing multiple activities across multiple assets.

• Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.

• Experience with project management and resource management systems, tools, & reporting features

• Ability to effectively lead multidisciplinary team meetings drive discussions regarding, timelines, resource allocation, risk management, etc.

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.

• Ability to effectively interact through different levels in the regulatory organisation and with stakeholders outside of regulatory with ability to persuade and influence others (regardless of level) in achieving team objectives.

• Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.

• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of project progress/status.

• Role requires extensive matrix interaction and leadership within the R&D environment to achieve consensus on project deliverables, meet demanding timelines, and retain compliance to external and internal requirements.

• Must have established project management and prioritisation skills to enable successful delivery of projects and initiatives.

• Must be able to work with minimal supervision in a complex organization driving the delivery of key departmental objective

Why GSK?

At GSK we offer a wide range of additional benefits: 

• Career at one of the leading global healthcare companies

• Hybrid work ( 2/3 days per week from the office)

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Company Car

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities). 

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

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Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.
GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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