Regulatory Manager, Delivery – CMC RA

You will lead and coordinate delivery of CMC (Chemistry, Manufacturing and Controls) regulatory activities to support timely submissions and lifecycle management of. You will work closely with regulatory colleagues, quality, supply chain, external partners and project teams. We value clear communication, practical problem solving, collaboration, and a growth mindset. This role offers strong learning and career growth, the chance to shape regulatory strategy, and meaningful impact in delivering safe, high-quality medicines aligned with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

This is an individual contributor role and does not include people management responsibilities.

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

• Lead planning, coordination and delivery of complex CMC submissions and post-approval changes across multiple products and markets across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards. ​
• Manage multiple variation projects simultaneously, including source document review for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers).
• Coordinate cross-functional inputs from quality, supply chain, manufacturing, and external partners to create submission-ready documentation.
• Track project timelines, identify risks, and implement mitigation actions to meet regulatory milestones.
• Respond to questions from health authorities and support regulatory negotiations and interactions.
• Serve as Subject Matter Expert (SME)  for CMC Regulatory Affairs, mentoring and guiding team members,  while sharing best-practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions. Drive improvements to regulatory processes, tools and templates and share best practices across teams.

Why You?
This role is hybrid. You will be expected to work from our GSK office minimum 2 days per week.

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

• Bachelor’s degree in pharmacy, chemistry, biochemistry, biotechnology, biology or a related life science.

• At least 8 years’ experience in regulatory affairs or CMC delivery within the pharmaceutical or biotech industry.

• Practical experience authoring CTD Module 3 (Quality) content and handling post-approval variations.

• Strong project coordination skills with experience managing multiple stakeholders in a matrix environment.

• Clear written and spoken English and strong interpersonal communication skills.

• Track record of delivering to deadlines with attention to detail and quality.

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

• Master’s degree or higher in a relevant scientific discipline.

• Experience with global submissions for Vaccines and familiarity with EU and US regulatory processes.

• Experience responding to health authority questions and managing regulatory interactions.

• Knowledge of change control, GMP interfaces and quality systems as they relate to CMC.

• Experience with regulatory document management systems or regulatory information tools.

• Demonstrated ability to drive process improvements or participate in digital transformation projects.

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, LTI, company car).

• 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

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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 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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