You will join our Biopharm Mature Products delivery team in Poland. You will coordinate regulatory and lifecycle activities for mature products across multiple markets. You will work with colleagues in CMC Regulatory Strategy Team, supply, quality, IT and external partners to ensure timely, compliant delivery. We value clear communicators who solve problems, improve processes and focus on impact. This role offers visible responsibility, learning opportunities and a chance to support GSK’s mission of uniting science, technology and talent to get ahead of disease together.
Key Responsibilities:
Coordinate end-to-end delivery of regulatory lifecycle activities for mature biopharmaceutical products, which includes CMC variations, handling Health Authority Questions (HAQs) and Post Approval Commitments (PACs).
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, drive issue resolution with stakeholders and escalate when needed to protect delivery and compliance and maintaining regulatory records and share knowledge across teams.
Support system administration, user training and user acceptance testing for regulatory and submission systems.
Building and maintaining strong relationships with internal and external stakeholders and 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.
Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
Mentor colleagues, share best practice and support cross-functional projects to improve delivery.
Why You?
Basic Qualification:
Bachelor’s or Master’s degree in life sciences, pharmacy, chemistry or a related technical field.
Minimum 5 years’ experience in regulatory operations, submission delivery or related roles in the pharmaceutical or biopharma sector.
Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
Practical experience with dossier management, document control and lifecycle maintenance activities.
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.
Experience using document repositories or collaboration platforms such as SharePoint.
Strong organisational skills, attention to detail and ability to meet deadlines.
Why GSK?
Career at one of the leading global healthcare companies.
Contract of employment.
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
Life insurance and pension plan.
Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
Sports cards (Multisport).
Possibilities of development within the role and company’s structure.
Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
Supportive community and integration events.
Modern office with creative rooms, fresh fruits everyday.
Free car and bike parking, locker rooms and showers.
#LI-GSK #LI-Hybrid
The annual base salary in Poland for new hires in this position ranges from PLN 144,750 to PLN 241,250 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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