Submission Coordinator

**Site Name**: Mexico City Torre Mitikah**Posted Date**: Jul 9 2025In this role, the position holder will be responsible for coordinating major and lifecycle regulatory submissions in our market expansion regions, managing and tracking project timelines, communicating with regulatory and operational staff across various functions, maintaining submission workplans and up-to-date knowledge of global regulations and guidelines to support internal stakeholders. The position holder will work closely with the Global Regulatory Lead (GRL)/Regional Representative (Therapeutic Group)/European Union Agent/Local Operating Company (LOC or equivalent) and functional teams to coordinate the appropriate content for specific submission packages within the Regulatory Vault system, maintain an accurate and current project plan and drive team members to deliver compliant submission dossiers to accelerated timelines.**Responsibilities**- ** Accountable for timely and quality delivery** of assigned regulatory submissions (EU, US, ROW), including new registrations, line extensions, variations, and pediatric submissions, with input from cross-functional teams.- ** Coordinates market expansion activities** and manages multiple regulatory projects of varying complexity, ensuring alignment with global and market-specific requirements.- ** Possesses deep regulatory knowledge** and company process expertise, providing training, consultation, and cross-functional support, including interpretation of guidance and issue resolution.- ** Executes dossier strategy independently**, escalating issues with potential business impact and offering solutions; supports scenario planning for multiple regulatory pathways.- ** Engages with regulatory agencies** as needed to resolve submission-related issues and contributes to defining regulatory strategies to meet accelerated timelines.- ** Leads or supports continuous improvement efforts**, reviewing peer work, identifying process enhancements, and contributing to optimization of regulatory systems and policies.**Basic Qualifications**- Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.- Solid knowledge of the pharmaceutical industry and regulatory landscape, including global regulations, guidelines, and drug development processes.- Proficient in using RIM systems to meet submission objectives while maintaining compliance and data quality.- Strong communication and organizational skills, with a focus on detail, clarity, and delivering high-quality work under tight deadlines.- Proven ability to manage multiple projects, prioritize tasks, and adapt to shifting timelines and priorities.- Effective team player in a matrix environment, able to build strong relationships and provide guidance on regulatory requirements globally.**Desirable skills**- Masters degree or higher in biological or healthcare science**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.**_Important notice to Employment businesses/ Agencies_