Job Purpose

Join Our Team as a Regulatory Asset Oversight Manager!

Are you prepared to drive innovation and efficiency in regulatory project management? Collaborate with global teams, manage integrated regulatory plans, and ensure the success of our R&D pipeline. In this role, you will facilitate the running of Regulatory Matrix Teams, act as a conduit for the Global Regulatory Lead, and engage with key partners outside of regulatory. If you are committed to accelerating compliance and delivering excellence, we invite you to apply and make a significant impact on patient care.

Details (Your Responsibilities):

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.
• Employing 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 RMTs and Submission Delivery Excellence colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
• Coordinate 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 identify upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to Sr. Manager, Regulatory Asset Oversight, and leadership as required.
• Utilizes 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. Contributes to Regulatory Asset Oversight function metrics and KPIs.
• Leverages data from RIM systems to support RMT needs, ensuring its accurate, complete, 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.
• May 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
• Networks with peers and colleagues to further develop required skillset.

Why You?

Basic Qualifications:

• Degree in a biological, healthcare, or scientific discipline or experience within the drug development environment
• Project or submission management/coordination experience in an R&D environment; Regulatory Health Authority requirements
• Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Experience 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.
• Knowledge of 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.
• Good 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 organization 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.

Preferred Qualifications:

• Professional experience in a Submission delivery or Project Management role
• Regulatory Submission delivery or Project Management

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

*This is a job description to aide in the job posting but does not include all job evaluation details.

#LI-GSK

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 employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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