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.
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Our approach to R&D
As a Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery Team you’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You’ll be responsible for preparing technical documentation for global regulatory changes, responding to Regulatory Agency inquiries, and providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
In this role, you’ll collaborate with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer (OCMO) to produce high-quality components for global regulatory dossiers. Additionally, you’ll have the opportunity to mentor and train new team members, contributing to the growth and success of the team.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).
Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.
Preparing and coordinating the review and approval of submission-ready documents.
Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.
Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.
Building and maintaining strong relationships with internal and external stakeholders.
Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
Identifying improvement opportunities for CMC regulatory processes, policies, and systems.
Why You?
Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
Thorough understanding of change management processes and regulatory requirements.
Attention to detail with an emphasis on accuracy and completeness.
Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
Flexible and analytical thinking to independently provide solutions to issues.
Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
Excellent written and verbal communication skills in English.
Working arrangement
This role is based in Poland and is offered as a hybrid position. You will be expected to attend the office regularly for team collaboration and stakeholder meetings.
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.
The annual base salary in Poland for new hires in this position ranges from PLN 131,250 to PLN 218,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. 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 market rate for the role.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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