Site Name: Mexico City Torre Mitikah Posted Date: Feb 13 2025 Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver E2E submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices. Coach other team members and reviews work to ensure right first-time submissions. This individual contributor role will give you the opportunity to: Work closely with GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices Responsible for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc) Perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines. Liaise with Regulatory Agencies to resolve issues in relation to their accountabilities Be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development) Work closely with project teams and client groups on GSK submission related processes and content and format requirements for key markets Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor degree or higher in biological or healthcare sciences. Strong experience within Regulatory Affairs in the Drug development environment and R&D in pharmaceutical industry. General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV . Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment. Advanced English. Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome. Excellent written and verbal communication skills and ability to present information in a clear and concise manner. Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools. Ability to influence others in a matrix environment and ensure delivery of objectives across cross-functional teams. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Our inclusive workplace makes our employees feel engaged by the contribution they make, by affording them equal treatment regardless of actual or perceived characteristics. As so, when you apply for a job at GSK, it is not necessary to include on your resume information such as: race, color, ethnicity, age, gender, sexual orientation, marital status, religion, origin, photographs or any other personal characteristics. Find out what life at GSK is really like www.gsk.com.