The Senior Regulatory Specialist is responsible for ensuring timely delivery of regulatory activities across multiple projects and dosage forms, meeting submission timelines and quality standards. Acting as the New Registration CMC representative on Regulatory Networks and Matrix Teams, the role provides regulatory guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ), and the Office of the Chief Medical Officer (OCMO) to enable preparation of appropriate components for global dossiers. The post-holder mentors and trains new team members to support their development and integration into regulatory workstreams. They also serve as a Subject Matter Expert for specific CMC/regulatory areas, offering consultation and expertise both within the department and to external stakeholders.
Key Responsibilities:
Independently develop and execute agreed dossier strategy to meet regulatory and business objectives.
Manage multiple projects simultaneously, handling varying complexity and delivering outcomes on time.
Conduct thorough data assessments to ensure dossiers are complete, accurate and fit-for-purpose.
Identify, document and mitigate risks related to submission data and information packages.
Escalate critical issues to line management when they have business impact and support resolution.
Review peers’ dossiers, recommend improvements, and contribute to enhancements of Regulatory processes, policies and systems.
Act as subject-matter expert on applicable regulations, guidelines and procedures for product registration and manufacturing; provide consultation, training and mentoring to colleagues.
Build and maintain stakeholder relationships across GSK and externally, share knowledge, and communicate effectively to support project and policy objectives.
Why You?
Basic Qualification:
Bachelor’s degree in pharmacy, chemistry, biotechnology, life sciences or related technical field.
Knowledge of drug development and manufacturing and supply processes.
Knowledge of worldwide CMC post-approval regulatory requirements.
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager.
Service orientation, customer-focused.
Fluent written and verbal English.
What we offer:
Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
Hybrid working model ( 2/3 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.
#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 [اضغط هنا لمشاهدة البريد اﻹلكتروني] 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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