Senior Regulatory Specialist

GSK; Województwo mazowieckie; Hybrid; PLN 211,000 - 296,000; Full time

Job summary

A leading global healthcare company in Poland is seeking a Senior Regulatory Specialist to deliver high-quality CMC dossiers and ensure regulatory compliance. The role involves collaboration with cross-functional teams and requires a Bachelor's degree along with at least 3 years of experience in CMC. The position offers a hybrid work model and an attractive benefits package, including life insurance and private medical care.

Benefits

Annual bonus

Life insurance

Private medical package

Sports cards (Multisport)

Flexible working solutions

Qualifications

• Minimum of 3 years of experience in CMC.
• Confident in executing dossier strategies.
• Ability to identify and escalate issues effectively.

Responsibilities

• Deliver regulatory submissions and ensure compliance.
• Collaborate with cross-functional teams.
• Act as subject matter expert and mentor new staff.

Skills

Independently manages multiple projects

Strong organizational skills

Excellent communication skills

Understanding of global regulatory guidelines

Education

Bachelor's degree in Chemistry, Pharmacy, or related field

Job description

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. Find out more: Our approach to R&D.

Position Summary

This role is an exciting opportunity to make a meaningful impact in Regulatory Affairs of biopharmaceutical assets. As a Senior Regulatory Specialist, you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. You’ll collaborate with cross‑functional teams and a wide range of stakeholders from all over the world to deliver high‑quality CMC dossiers.

Basic Qualification

• Independently and confidently executes agreed dossier strategy.
• Minimum of 3 years of experience in CMC.
• Bachelor’s degree in Chemistry, pharmacy, or other related science or technical bachelor’s degree.
• Independently manages multiple bio‑pharm project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
• Independently completes data assessment to ensure dossier is fit for purpose.
• Identifies risks associated with submission data and information packages.
• Escalates issues with line manager that have business impact.
• May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for regulatory processes, policies and systems.
• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions as subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
• Understands internal/external regulatory environment.
• Actively builds an organizational network (GSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
• Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Preferred Qualification

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Global regulatory submission experience – Knowledge of regulatory agency guidelines.
• Excellent organizational skills, attention to detail and commitment to delivering high‑quality output, even under pressures sometimes demanded by regulatory deadlines.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience.
• Ability to build effective working relationships and work in a matrix environment effectively.
• Ability to think flexibly to meet constantly shifting priorities and timelines.

Work Environment

Hybrid work (2/3 days per week from the office).

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).
• Hybrid working model (where GSK sites are in Poland).
• Extensive support of work‑life balance (flexible working solutions, min. 2‑3 days/week working from the office, short Fridays option, health & well‑being activities).
• Life insurance and pension plan.
• Private medical package with additional preventive healthcare services for employees and their eligible dependents.
• Sports cards (Multisport).
• Possibilities of development within the role and company’s structure.
• Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
• Supportive community and integration events.
• Modern office with creative rooms, fresh fruits every day.

Inclusion at GSK

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 [e-mail] to discuss your needs.

Equal Opportunity Employer

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, military service or any basis prohibited under federal, state or local law.

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