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 prevent and treat disease with specialty medicines, vaccines and general medicines. We focus on the science of the immune system and advanced technologies, investing in four core 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 perform 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.
As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people’s lives. We focus on four areas – respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society.
Find out more:
Our approach to R&D.
Position Summary
The Regulatory Submission Lead independently manages regulatory submission activities—authoring, reviewing, and compiling dossiers and registration requirements for assigned deliverables in Veeva Vault—ensuring compliance with health authority regulations and GSK policies. The role coordinates with Submission teams, Local Operating Companies, and Global Regulatory/Functional teams, and mentors new team members.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Here’s a more concise, engaging version:
Deliver assigned submissions per dossier strategy, coordinating with Submission teams, LOCs and Global Regulatory/functional teams (e.g., CMC, Clinical) to meet agreed timelines in assigned markets.
Manage multiple complex projects concurrently (variations, PBRERs, renewals, site registrations/renewals, and complex tenders).
Handle complex registration requirements from agencies, manufacturing sites, or third parties, including providing site support to meet regulatory expectations.
Prepare, coordinate and ensure timely delivery of documents requested by health authorities, legalization providers, manufacturing sites or third parties.
Collaborate cross‑functionally and with senior process teams to advise, interpret guidance, research and resolve complex issues; provide training and tailored GSK process solutions.
Ensure dossiers meet EU, US and ROW regulatory requirements through independent data assessments to confirm fitness for purpose.
Conduct scenario planning for regulatory strategies, recommend accelerated delivery approaches, and proactively escalate business‑impacting issues with proposed solutions.
Review peer deliverables and drive improvements in regulatory processes, policies and systems to increase efficiency and innovation.
Engage with regulatory agencies to resolve issues within scope.
Apply deep knowledge of regulations, guidelines and manufacturing policies to expedite global submission, review and approval.
Communicate clearly with internal and external stakeholders on project and policy matters with minimal supervision to secure optimal outcomes.
Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
5 years of experience with a strong understanding of industry, drug development, and R&D processes.
In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
Proficient in using Veeva Vault systems to ensure efficient and compliant submission deliverables.
Excellent organizational, communication, and interpersonal skills, with a focus on delivering high-quality results under tight deadlines.
Skilled in interpreting global regulatory requirements and providing expert guidance based on recent GSK experience.
Adaptable and proactive in managing workloads, priorities, and timelines while effectively collaborating in a matrix environment.
Proven ability to handle multiple projects simultaneously and build strong relationships with internal stakeholders.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
Detailed knowledge of CMC (chemistry, manufacturing and controls) content requirements.
Experience working in a global, matrixed environment.
Demonstrated ability to engage and influence senior stakeholders.
Experience training or mentoring colleagues on submission processes.
Advanced degree in a scientific discipline or relevant professional certification.
Working model:
This is a hybrid role is based in Mississauga, Ontario, with an in-office expectation of 2-3 days per week and flexibility to work remotely the remaining days.
What you will gain
You will grow your regulatory expertise while working with diverse teams across the globe. You will shape processes that speed access to healthcare. You will be part of an inclusive culture that values learning, collaboration and well-being.
How to apply
If this role excites you, please apply. We welcome applications from people with different backgrounds and experiences. If you have questions about the role or need adjustments to apply, contact the recruitment team and we will support you.
#LI-Hybrid
The annual base salary in Poland for new hires in this position ranges from PLN 132,000 to PLN 220,000 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. In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD82,000 to CAD132,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our 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.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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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