Sr. Regulatory Specialist

**Site Name**: Mexico City Torre Mitikah, Mississauga Milverton Drive
**Posted Date**: Jul 7 2025

This role oversees the strategy and delivery of artwork across product lifecycles and markets (Global, Regional, Country), while managing vendor interactions to ensure quality and timely outputs. It involves regulatory pack advice, executing agreed artwork strategies, managing multiple projects, identifying risks related to labeling and packaging, and acting as a senior specialist to lead projects and support staff.

**Responsibilities**
- Timely management and communication of documentation to support global, regional, and country artwork development and maintenance throughout the product lifecycle, including launch into markets.
- Leverage regulatory and packaging knowledge to respond to content queries, interface with vendors and GSK functions, and ensure consistency in processes and practices.
- Accountable for developing packaging for new products and line extensions in line with regional requirements, ensuring accurate version control and resolving packaging issues proactively.
- Articulate Health Authority (HA) requirements for labelling documents, provide labelling components for HA submissions, and deliver input to regulatory questions related to centrally managed packs.
- Support labelling processes and systems in accordance with GSK policies, contribute to process changes, and identify improvement opportunities for labelling processes, policies, and systems.
- Lead multifunctional reviews of artwork labelling documents, facilitate consensus, and actively build organizational networks while supporting other labelling functions and projects.

**Basic Qualifications**
- Bachelor’s degree in life sciences or a related field.
- Strong relevant experience in the pharmaceutical industry and regulatory affairs, with knowledge of packaging artwork management and regulatory processes.
- Fluency in written and verbal English.
- Broad understanding of pharmaceutical regulations, drug development and packaging/labelling legislation.
- Document management and data entry/analysis skills.
- Ability to work in matrix team environments, participate/lead cross-functional teams, and solve problems proactively with mínimal supervision.

**Desirable skills**
- Master’s degree or equivalent experience in healthcare-related areas or regulatory pack management/artwork.
- Attention to detail, organization, and time management, with the ability to prioritize and work under time constraints.

**Why GSK?**

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).

At GSK, we value all perspectives and foster a culture of respect and collaboration within an inclusive environment, focused on the well-being of our team members. If you require any type of accommodation and/or support during the selection process to better showcase your abilities (for example, access to ramps, accessible emergency exits, visual aids, etc.), please let us know when we contact you. We are here to support you.

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