Senior Specialist, Regulatory Operations

Are you passionate about driving innovation at the intersection of business and technology? Join GSK's Regulatory Operations Function and play a key role in maximizing the value of IT systems and business processes! In this dynamic role, you'll optimize the collaboration between Regulatory business groups and IT teams—both in-house and with vendors—ensuring seamless interaction and the efficient use of cutting-edge technology. Be a part of a forward-thinking team dedicated to advancing regulatory excellence and making an impact on the future of healthcare. This role serves as the Business System Owner (BSO) for a number of systems in the Labelling Operations space.

This position can be filled in Mississauga, Canada or Mexico City

Key Responsibilities

• Lead and coordinate the business engagement in projects in collaboration with IT and Business Project Teams to coordinate solutions delivery and support.
• Lead workshops with business experts to agree requirements – using good facilitation and influencing skills.
• Define and document user requirements.
• Recommend improvements to or new processes to support implementation.
• Design solutions using knowledge of tools (e.g. Cognos).
• Apply knowledge of data migration processes to ensure a robust solution is identified.
• Manage and perform User Acceptance Testing within the project lifecycle.
• Represent Regulatory Systems in cross-Regulatory initiatives, taking a lead role to define requirements, identify proposals, and lead implementation.
• Contribute to the development of project proposals and business cases.
• Identify process improvement opportunities and work with senior managers to gain endorsement to implement.
• Lead support for a varied portfolio of off-the-shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
• Provide operational support to GRC for Regulatory Systems.
• Mentor junior staff within the team on processes and tools.

Basic Qualifications

• Bachelor's degree in a scientific or technical area of specialization.
• Experience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems).
• Experience managing/supporting regulatory business IT systems is a must-have.
• Experienced in leading and participating in Business Change Teams delivering IT solutions for the business.
• Extensive experience of working within a regulated project delivery environment.
• Ability to communicate and provide assistance and support on both sides of the Business-IT interface.
• Proven ability to effectively interact with senior managers within the organization.
• Experience managing change control and system lifecycle within a regulated environment, ideally in drug/vaccines development.
• Experience in Business Analysis and Business Process Design.

Preferred Qualifications

• Experience with business system ownership and business system lifecycle management.
• Strong understanding of CFR Part 11, Annex 11, Data Integrity principles, and GAMP 5 methodology.
• Fluent and able communicator in English and local language.
• Strong communication and influencing skills.
• Ability to self-manage work and prioritize effectively.
• Service orientation, customer-focused.
• Good team worker, but with confidence to lead when appropriate.
• Good understanding of IT lifecycle, processes, and quality management.
• Software and System Experience (any):
• Parexel Insight Manager – RIM and Cognos Reporting
• Documentum D2 – Labeling System
• CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)
• Global Submit Validate – Lorenz eValidator
• Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP
• Veeva Regulatory Vault
• PowerBi
• SharePoint

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 organization 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 well-being. 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 committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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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