Senior Regulatory Specialist, Regulatory Asset Oversight (temporary contract)

Senior Regulatory Specialist, Regulatory Asset Oversight (temporary contract)

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer. 

We are currently seeking Senior Regulatory Specialist to join our GRO Regulatory Asset Oversight team. In this role, you will be involved in impactful initiatives, drive operational efficiency, and foster innovation, contributing to the delivery of life-saving vaccines to patients worldwide.

Role purpose

The Senior Regulatory Specialist, Regulatory Asset Oversight drives the operational delivery of the Global Regulatory Strategy by creating and managing integrated regulatory plans and delivering fit-for-purpose regulatory workstreams. This role focuses on Smartsheet administration, regulatory reporting and data integrity to provide transparent, real-time submission status and ensure teams meet submission and compliance objectives across R&D and regulatory stakeholders.

Key Responsibilities include

As a Senior Regulatory Specialist (Regulatory Asset Oversight), you will:

• Administer and configure Smartsheet for ISP 2.0/3.0 workflows: build and optimize sheets, forms, automations and integrations to support regulatory processes.
• Develop, maintain and distribute interactive compliance dashboards and visual reports (Smartsheet dashboards, Power BI) to provide real-time submission status and regulatory compliance across markets.
• Deliver accurate, up-to-date submission status visuals and reports for Regulatory Management Teams, reflecting status from central dispatch to market registration.
• Ensure data integrity across RIM and other source systems feeding Smartsheet: validate, cleanse, transform and reconcile data to be complete and fit for purpose.
• Design and enforce standardized Smartsheet templates, automations and governance to harmonize ways-of-working across SDE teams.
• Provide technical support and troubleshooting for Smartsheet and reporting tools; create user guides, templates and run user training to drive adoption and consistency.
• Produce system-based reporting for Regulatory Asset Oversight KPIs and contribute to trend analysis to support decision-making.
• Recommend system enhancements and best practices through continuous improvement initiatives, liaising with IT and cross-functional teams as needed.
• Communicate technical and project issues across GSK to ensure alignment and optimal regulatory positioning.

Required Skills and Qualifications

We’re seeking professionals who bring:

• Bachelor’s degree in Chemistry, Pharmacy or related biological or technical science.
• Strong English language skills (written and verbal).
• Understanding of pharmaceutical R&D, regulatory processes and submission lifecycle.
• Proven hands-on experience with Smartsheet administration and configuration (sheets, forms, automations, integrations).
• Experience building interactive dashboards and reports (Power BI and/or Smartsheet dashboards).
• Knowledge of RIM systems and data flows, with experience validating, cleansing and transforming regulatory data.
• Familiarity with project/resource management systems and reporting features.
• Strong technical problem-solving skills, attention to detail and ability to prioritize in a deadline-driven matrix environment.

What we offer:

• Performance with Choice – flexibility in working mode (hybrid working model  2/3 days per week in the office), flexible working hours.
• Established job in an international, well-known pharmaceutical company.
• Opportunity to work in professional team playing 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.

We’re 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, we’d love to hear from you!

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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 pl.recruitment-adjustments@gsk.com 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 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.

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