Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery Team

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Location: Warsaw, Poland

Responsibilities

• Ensure timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.
• Prepare technical documentation for global regulatory changes.
• Respond to Regulatory Agency inquiries.
• Provide expert guidance on CMC variations for active pharmaceutical ingredients (APIs), intermediates, and drug products.
• Collaborate with Global Regulatory, Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer to produce high‑quality components for global regulatory dossiers.
• Mentor and train new team members.
• Manage multiple project assignments, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for finished products, intermediates, and APIs.
• Execute agreed dossier strategies, complete data assessments, and ensure dossiers are fit for purpose and compliant with GSK regulatory processes and external market requirements.
• Prepare and coordinate the review and approval of submission‑ready documents.
• Collaborate with Product Owners/Project Managers to provide regulatory support for assigned projects.
• Work with colleagues worldwide to deliver dossiers on time.
• Build and maintain strong relationships with internal and external stakeholders.
• Monitor regulatory intelligence and proactively act on identified changes to regulatory requirements.
• Identify improvement opportunities for CMC regulatory processes, policies, and systems.

Qualifications

• Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or a related science or technical field.
• Relevant experience in regulatory affairs within 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.

Benefits

• Performance with Choice – flexibility in working mode (hybrid, 2–3 days per week in office) and flexible working hours.
• Established position within an international, well‑known pharmaceutical company.
• Opportunity to work in a professional team playing a crucial role in maintaining GSK’s portfolio in 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 and friendly working environment.

Salary & Compensation

Annual base salary in Poland ranges from PLN 131,250 to PLN 218,750 gross, depending on experience, education level and market rate for the role. Additional benefits may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.

Inclusion & Equal Opportunity

GSK is an Equal Opportunity Employer. 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, military service or any basis prohibited under federal, state or local law. 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.