Regulatory Manager, Delivery - Licence Maintenance

 

As Regulatory Manager, Delivery – Licence Maintenance, you will lead the efficient delivery and high quality of CMC (Chemistry, Manufacturing, and Controls) regulatory outputs and licence maintenance activities across GSK’s product portfolios. You will oversee the authoring, review and approval of complex CMC submissions and market-specific requirements, guide cross-functional teams to secure timely regulatory approvals and lifecycle management, and proactively manage risks to achieve optimal regulatory outcomes aligned with GSK’s business objectives. You will also help drive continuous improvement and digital transformation of CMC regulatory processes, strengthening regulatory capabilities and developing subject matter expertise within the team.

 

We value clear communication, strong digital and data skills, practical problem solving, collaboration and a growth mindset. This role offers the opportunity to shape how we deliver CMC regulatory strategy and licence maintenance globally, while developing yourself and others.

 

Responsibilities

 

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios by overseeing the authoring, review and approval of high-quality CMC submissions and variations, including market-specific requirements.
• Ensure efficient delivery and high quality of CMC outputs and that effective regulatory processes are followed to assess and assure the quality, reliability and consistency of data used in regulatory submissions.
• Independently manage multiple complex CMC project assignments simultaneously, including planning, tracking and reporting against key milestones and regulatory timelines.
• Coordinate cross-functional inputs from CMC Regulatory Affairs, Global Supply Chain, local operating companies, quality, manufacturing and external partners to produce submission-ready documentation and smooth delivery of CMC projects.
• Prepare, analyze data and author complex CMC technical regulatory documents to support marketing authorizations, lifecycle activities and maintenance of registered products.
• Understand and apply regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications.
• Identify risks associated with submission data and information packages, influence people, systems and processes, and propose alternative approaches; escalate matters that affect corporate or agency policies as appropriate.
• Drive continuous improvement for defined and new CMC regulatory processes, including leading or contributing to digital transformation and process-automation initiatives across CMC Regulatory Affairs.
• Champion the adoption of digital tools, RIM systems, dashboards, structured data tools and AI-supported workflows to improve CMC submission quality, efficiency and data stewardship practices.
• Strengthen CMC regulatory capabilities by mentoring and/or training staff, developing subject matter experts and guiding teams in using digital tools and data-driven approaches.
• Maintain appropriate organizational networks and partnerships with key stakeholders (e.g. CMC RA stakeholders, GSC, LOCs, senior leadership) and contribute to interactions with worldwide regulatory authorities as needed.
• Track, analyze and report on team performance against key performance indicators using digital dashboards and performance analytics, ensuring digital best practices and accuracy of structured regulatory data across global submissions.
• Provide CMC regulatory support and advice to in-licensing, divestment projects and R&D teams, as required.

 

Work arrangement

 

This role is hybrid. You will be expected to work from the office at least two days per week.

Basic Qualifications

 

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

 

• Bachelor’s degree in a scientific or technical field (e.g. pharmacy, chemistry, biochemistry, biotechnology, biology or related life sciences).
• Extensive, demonstrable experience handling complex global CMC submissions and regulatory issues, with detailed working knowledge of worldwide CMC regulatory requirements.
• Strong experience in regulatory affairs within the pharmaceutical or biotech industry, with expertise in regulatory strategy planning, dossier preparation, technical dossier review and CMC lifecycle management.
• Proven project management and multi-tasking skills, with the ability to manage matrix teams and direct multiple projects simultaneously.
• Successful track record of working in regulated or quality-critical environments such as pharmaceutical industry research or regulatory roles.
• Strong digital leadership skills and high digital fluency, including proficiency with RIM systems, dashboards, structured data tools and AI applications used in CMC regulatory delivery.
• Recognized CMC regulatory expertise in one or more subject areas, with highly developed interpersonal, presentation and communication skills.
• Experience supervising and training staff and guiding teams in using digital tools and driving a data-driven approach.
• Attention to detail, excellent organization and time management skills, with the ability to handle multiple projects for different stakeholders.
• Excellent written and verbal communication skills in English.

 

Preferred Qualifications

 

If you have the following characteristics, it would be a plus:

 

• Master’s degree or higher in a relevant scientific discipline (life sciences or related field).
• Experience leading or significantly contributing to digital transformation and process-automation initiatives within CMC Regulatory Affairs.
• Experience interacting with worldwide regulatory authorities and supporting in-licensing and divestment projects or R&D teams.
• Demonstrated ability to influence and negotiate with stakeholders in a variety of settings and to shape the internal/external regulatory environment.
• Experience tracking and reporting performance using digital dashboards and performance analytics, with a focus on structured regulatory data quality.
• People management experience, including recruitment, coaching, training and development, and serving as a point of escalation for team members and stakeholders (where applicable to the specific posting level).

What we offer:

• 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!

#LI-GSK

#LI- Hybrid

Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

 

 

Polish Salary Range / Polski przedział wynagrodzenia: PLN 236,250 to PLN 393,750The 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 other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne, ponieważ na niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń, które wymagają zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.

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 [email protected] 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.

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