Senior Regulatory Specialist

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 peoples 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.

Were 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 asset/s. As a Senior Regulatory Specialist you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. Youll collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Independently and confidently executes agreed dossier strategy.
• Minimum of 3 years of experience in CMC
• Bachelors degree in Chemistry pharmacy or other related science or technical bachelors degree.
• Independently manages multiple BioPharm 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 being the 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
If you have the following characteristics it would be a plus:

• 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 deliver 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 in order to meet constantly shifting priorities and timelines

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

We encourage you to apply and bring your unique skills and experiences to GSK. Together we can make a difference in global healthcare.

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 to discuss your needs.

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 peoples 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.

Were 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 asset/s. As a Senior Regulatory Specialist you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. Youll collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Independently and confidently executes agreed dossier strategy.
• Minimum of 3 years of experience in CMC
• Bachelors degree in Chemistry pharmacy or other related science or technical bachelors degree.
• Independently manages multiple BioPharm 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 being the 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
If you have the following characteristics it would be a plus:

• 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 deliver 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 in order to meet constantly shifting priorities and timelines

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 site are in Poland)

• Extensive support of work life balance (flexible working solutions min. 2-3 days/week working form 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

• Sports cards (Multisport)

• Possibilities of development within the role and companys 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 to discuss your needs.

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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 were 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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Senior IC