Submission Lead

Position Summary

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

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.

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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 canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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