Senior Manager, Regulatory Asset Oversight

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D

Position Summary
The Senior Manager, Regulatory Asset Oversight will partner with the GRL (Global Regulatory Lead) 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. As Senior Manager, Regulatory Asset Oversight you will create and manage integrated regulatory plans, and ensure team is on track to deliver per the Regulatory strategy. 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. 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. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work

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

• Develop and maintain a holistic view of the global regulatory integrated plan at the asset level in collaboration with the GRL and RMT.
• Drive the execution of agreed plans, performing scenario planning, impact analyses, and risk mitigation.
• 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 ide
• 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.

Why You?

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
• 5 years of regulatory affairs experience or similar relevant project management, experience
• 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 diverse stakeholders and multifaceted assets
• 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.
• Commutable distance to our hubs in Mexico City, Mississauga, Ontario, Poznan, Poland and Central London, UK.

Preferred Qualifications
If you have the following characteristics, it would be a plus:

• Training in project management skills/ tools, PMP a plus
• 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.
  

Work Arrangements
This role offers a hybrid work arrangement based in Mississauga, Ontario, Mexico City, Mexico, Central London, UK and Poznan, Poland requiring 2-3 days per week onsite, balancing collaboration and flexibility. Fully remote work is not available for this position.

If you are ready to make a real impact in healthcare and grow in a supportive, forward-thinking environment, we encourage you to apply and join us in our mission to get ahead of disease together.

#LI-Hybrid

Skills

Agile Planning, Business Acumen, Change Management, Digital Fluency, Influencing Without Authority, Learning Agility, Problem Solving, Regulatory StrategiesPolish Salary Range / Polski przedział wynagrodzenia: PLN 288,000 to PLN 480,000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

GSK uses artificial intelligence (AI) tools as part of the recruitment process to assist in screening and assessing applicants. Final hiring decisions are made by hiring managers, with support from recruiters.

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This advertisement relates to a current vacancy.