Manager, Regulatory Registration Requirements, Submission Delivery Excellence

The job holder is responsible for managing end-to-end preparation of regulatory registration requirements needed for Health authority submissions across multiple markets, ensuring timely, high-quality deliverables that meet regulatory authority expectations, applicable guidance, and GSK processes, including written standards. The role coordinates with cross-functional teams to execute regulatory submission strategies, mentors and develops team members, and ensures consistent application of regulatory registration requirements processes, to maintain regulatory compliance and support GSK's global product strategy. This role involves serving as a Subject Matter Expert to address escalations and drive improvements in regulatory processes, supporting organizational objectives and ensuring compliance with global regulatory standards.

Responsibilities

• Own the end-to-end delivery of complex regulatory registration requirements for submissions (e.g., certificates, market-specific requirements, samples…), ensuring alignment with Health authority expectations, agreed dossier strategies, and timelines, while proactively identifying risks and driving effective mitigation.
• Lead the preparation and technical review of multi-market regulatory registration requirements deliverables, ensuring high-quality, compliant submissions that meet GSK standards, regulatory guidance, and the needs of diverse health authorities.
• Apply subject-matter expertise to lead and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to written standards and controlled documents.
• Develop and sustain collaborative cross-functional relationships with internal and external GSK stakeholders like manufacturing sites, regulatory authorities or third-party service providers to coordinate submission deliverables, address concerns, resolve issues and implement fit-for-purpose regulatory strategies.
• Drive continuous improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation point for submission issues affecting timelines or market access.
• Maintain own project accountabilities, escalate business-critical risks and ensure compliance with corporate and regulatory policies.

Qualifications

• Bachelor's degree or higher in pharmaceutical, biological or healthcare science.
• Significant relevant regulatory/submission experience with local health authorities, along with a strong understanding of the varying levels of stringency in international regulations.
• In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing, including strong awareness of GMP principles.
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Strong written and verbal communication skills with the ability to convey information clearly, influence stakeholders, and engage effectively with management, staff, and external partners in a complex matrix environment.
• Demonstrated agility in adapting to rapidly changing priorities and timelines while maintaining high-quality outcomes.

Preferred Qualifications & Skills

• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Strong understanding of regulatory information systems, with expert proficiency in Microsoft Office and advanced digital skills, complemented by experience in data analysis, and reporting.
• Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools.
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
• 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 submission progress/status.
• Demonstrated problem-solving mindset, applying analytical thinking and structured approaches to resolve complex issues and drive continuous improvement.

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.

Salary and benefits details: The annual base salary in Poland for new hires in this position ranges from PLN 198,000 to PLN 330,000 gross, with eligibility for bonus and/or awards where applicable. Statutory benefits will be maintained according to Polish law. Other benefits may include private healthcare, additional paid days off, life insurance, private pension plan and parental leave & care leave. Details provided during recruitment. Salaries vary by country based on market rate. GSK is an Equal Opportunity Employer. We support flexible working arrangements and provide adjustments upon request through the recruitment team.