Senior Manager, Regulatory Asset Oversight

The Senior Manager 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. 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 practices and this role operates under a hybrid working model only. Our Performance with Choice programme empowers you to find the optimal balance between remote and in-office work within this framework.

In this role you will

• 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
• 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.

Why you

Working arrangement

This role is hybrid. You will be expected to work regularly from our office in Poland and collaborate with international colleagues.

Basic Qualifications & Skills:

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.

Preferred Qualifications & Skills:

Please note the following skills are not necessary just preferred if you do not have them please still apply:

• Training in project management skills/ tools
• 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 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.

What we offer:

• Performance with Choice flexibility in working mode (hybrid working model2/3 days per week in the office) flexible working hours.
• Established job in an international well-known pharmaceutical company.
• Opportunity to work in professional team plays crucial role in maintaining GSK portfolio on the markets.
• Opportunity to work within GSK standards and documentation applied globally.
• Wide range of benefits (Medical Plan Life Insurance Employee Retirement Program Sport and recreation cards Recreation allowance annual bonus).
• Supportive & friendly working environment.

Were looking for someone who thrives in a collaborative environment is passionate about delivering results and is eager to make a difference. If this sounds like you wed love to hear from you!

#LI-GSK

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As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs.

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 were 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.

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Senior Manager