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 highquality 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 GSKs 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.

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

• Own the endtoend delivery of complex regulatory registration requirements for submissions (e.g. certificates marketspecific 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 multimarket regulatory registration requirements deliverables ensuring highquality 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 crossfunctional relationships with internal and external GSK stakeholders like manufacturing sites regulatory authorities or third-party service providers to coordinate submission deliverables address concern resolve issues and implement fitforpurpose 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 businesscritical risks and ensure compliance with corporate and regulatory policies.

Why you

Basic Qualifications & Skills:

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

• Bachelors 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:

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

• 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 problemsolving mindset applying analytical thinking and structured approaches to resolve complex issues and drive continuous improvement.

Closing Date for Applications 20th of February 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.

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 peoples 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. Were uniting science technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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Manager