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Ensure the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s) consistent with relevant enterprise goals and respective product profile. This goal has to be achieved as a component of an overall global regulatory approach while ensuring compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling, in a close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads. Being dedicated SPoC for given asset(s), the Regional Regulatory Manager keeps continuous engagement with LOCs, GRLs and regional stakeholders to enable right pace and alignment in project planning and execution.

Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan. In conducting role, planning of given asset(s) will be on a multiple year horizon, with delivery requiring matrix working with support from the Regional Regulatory Leads. The Regional RA Manager is the regional single point of contact on assigned asset(s), accountable for liaison between GRLs, Medical, and Regional Commercial Leads, as well as the (LOC RA) in region with the goal to deliver best-in class regulatory strategy, achieve the cross-regional alignment and regional objectives.

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.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

• Lead the development and execution of regional regulatory strategy for assigned assets, aligned with global strategy and regional requirements
• Act as the single point of contact for regional regulatory, ensuring alignment across Global Regulatory Leads (GRLs), local regulatory teams, and cross-functional stakeholders
• Provide regulatory expertise and market insight to anticipate risks, identify opportunities, and support decision-making
• Drive delivery of submissions and approvals, ensuring timely, compliant execution across the region
• Collaborate with global and local teams to integrate regional requirements into development plans, including clinical, GMP, and submission strategies
• Ensure clear communication of regulatory plans, milestones, risks, and strategic implications to stakeholders
• Support continuous improvement, innovation, and knowledge sharing across regulatory teams

Why you?

Basic Qualifications & Skills:

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

• Bachelor's Degree in Biological or Healthcare Science
• Strong experience in regional regulatory strategy, submissions, and approvals
• Knowledge of clinical development, regulatory requirements, and agency processes
• Ability to work cross-functionally and influence stakeholders in a matrix environment
• Strong decision-making and problem-solving skills with ability to assess regulatory impact
• Proven ability to manage complexity, anticipate risks, and drive solutions
• Digital fluency and ability to leverage tools to enhance delivery and efficiency

Preferred Qualifications & Skills:

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

• PhD in Biological or Healthcare Science
• Experience of all phases of the drug development process in regulatory affairs preferred.

Closing Date for Applications - 27th of May 2026 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people's lives. We focus on four areas - respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society.

Find out more:

Our approach to R&D.

#LI-GSK

The annual base salary in Poland for new hires in this position ranges from PLN 291,000 to PLN 485,000 gross, taking into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer's discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.

Italian Salary Range / Fascia retributiva in Italia: EUR 57,675 to EUR 96,125

Belgium Salary Range / Fourchette salariale - Belgique: EUR 89,250 to EUR 148,750

The 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...