Senior Submission Specialist

Please note that this role will be posted until 7/18; application review will begin after that date

Are you ready to take your career to the next level with one of the world’s leading research-based pharmaceutical companies? At GSK, we’re united by our mission to improve global healthcare through science-driven innovation. As part of our Global Regulatory Operations team, you’ll play an integral role in delivering life-changing medicines and vaccines to patients worldwide.

We are seeking a Senior Specialist to join our Submission Delivery Excellence, Submission Technical Support Team based in Mississauga. This is an exciting opportunity to contribute to GSK’s groundbreaking work in Pharmaceuticals, Vaccines, and Consumer Healthcare while growing your expertise in regulatory operations within a global environment.

As a Senior Specialist, you will be responsible for ensuring the timely delivery of high-quality, CMC-compliant regulatory submission packages to Health Authorities across the globe. You’ll collaborate with cross-functional teams and stakeholders, providing expert technical guidance to enable the successful submission of clinical applications and major marketing authorizations.

You’ll work within a dynamic and fast-paced environment, leveraging your regulatory knowledge, technical expertise, and project management skills to support GSK’s R&D strategic objectives. This role is pivotal in maintaining GSK’s product licenses and supporting the launch of innovative medicines and vaccines that improve lives around the world. ​

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

• Submission Delivery: Lead the preparation and on-time delivery of Module 2 (QOS) and Module 3 (CMC Standalone and Non-Standalone) electronic applications for regulatory submissions, including new chemical entities (NCEs), biologics, and lifecycle submissions.
• Stakeholder Collaboration: Represent CMC Publishing within Global Regulatory Matrix Teams, negotiating agreements on technical aspects and submission timelines to meet project needs.
• Publishing Planning: Collaborate with Global Publishing Leads, Submission Managers, and Global Regulatory Centres (GRCs) to estimate publishing tasks, plan resources, and ensure delivery against aggressive timelines.
• Technical Guidance: Provide expert advice and training to CMC Regulatory Executives and document authors, ensuring submission readiness and compliance with GSK standards.
• Regulatory Knowledge: Maintain up-to-date knowledge of Health Authority rules and guidance for regulatory submissions in multiple regions (e.g., eCTD format).
• Process Excellence: Build electronic submissions using validated processes, industry-standard software, and GSK SOPs while managing multiple projects at various stages of development.
• Team Support: Assist authors with complex content preparation, document management procedures, and populate templates for major applications.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in a biological, healthcare, or scientific discipline, or extensive experience within the drug development environment.
• 2 years of regulatory affairs experience
• 1- year experience in CMC Module 3 submissions
• 1-year Veeva Vault publishing experience
• Proficiency in formatting MS Word documents to meet GSK standards.
• Knowledge of document management and publishing software/tools.
• Familiarity with global regulatory requirements and submission standards.
• Strong project management skills with the ability to oversee multiple activities and prioritize effectively.
• Service-oriented mindset with excellent interpersonal skills to thrive in a matrixed, interdisciplinary environment.
• Ability to make informed decisions based on technical knowledge within a regulated framework.
• Team player with a proactive, solutions-driven approach.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced degree in a biological, healthcare or scientific discipline
• Master’s degree or MBA
• Experience working in a matrixed environment
• Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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