Regulatory Affairs Specialist at GSK

Ciudad de México, , Mexico -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

0.0

Posted On

18 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, Marketing authorization dossiers, COFEPRIS compliance, Lifecycle management, Regulatory strategy, CMC, Pharmacovigilance, Labelling and packaging reviews, Regulatory databases, Competitive intelligence, VEEVA, PowerBI, Risk mitigation, Regulatory guidance interpretation

Industry

Pharmaceutical Manufacturing

Description

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Position Summary In this role, you will support the preparation, submission and maintenance of marketing authorization dossiers and related regulatory activities for GSK products in Mexico, ensuring compliance with local regulations (COFEPRIS) and company procedures to enable timely product approvals and effective lifecycle management. The role requires alignment with the needs and strategies defined by the corresponding business unit of the company. The job holder will work closely with the Regulatory Affairs Manager, Coordinator and relevant central and local stakeholders to define a preliminary regulatory strategy and execute regulatory strategies defined by the RA Manager/Coordinator, mitigate risks, ensure effective internal communications, work closely with the regulatory team to ensure continues improvements in the regulatory way of working. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Prepare, compile and submit regulatory dossiers, variations, renewals and responses to COFEPRIS, ensuring adherence to Mexican regulatory requirements and GSK standards (including safety-related notifications). Coordinate cross‑functional inputs (CMC, clinical, pharmacovigilance, quality, supply) to deliver complete, high‑quality submissions and support labelling/packaging reviews. Maintain registration files and regulatory databases, track submission timelines, milestones and post‑approval commitments. Interpret and implement regulatory guidance, NOMs and company SOPs; provide clear regulatory advice and contribute regulatory input to lifecycle strategies and project plans. Identify and escalate regulatory risks, develop mitigation plans to prevent business disruption, and drive continuous improvement initiatives. Support competitive intelligence activities and communicate competitor/regulatory landscape insights to local stakeholders for priority products. Why You? Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor's degree in Pharmaceutical and Biological Chemistry, Biotechnology Engineering, Chemical Engineering, or related fields. 2 to 4 years of experience handling submissions (cancellations, renewals, new molecules). Advanced English proficiency. Knowledge of international regulations. Preferred Qualifications If you have the following characteristics, it would be a plus Experience working with VEEVA Experience working with PowerBI What we offer You will join a supportive team where you can grow your regulatory skills. You will gain hands-on experience with regulatory systems and cross-functional processes. You will have opportunities for training and career development that align with GSK’s mission to advance patient health. How to apply If this role feels like the next step for your career, please apply. We read every application and welcome concrete examples of your regulatory or systems experience. We look forward to hearing from you and exploring how you can help us get ahead of disease together. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. Your application is voluntary; therefore, you understand and consent that GSK, located at Real Mayorazgo 130, Torre M, Piso 20, Col. Xoco, Benito Juárez, Mexico City, will process your personal data to evaluate your candidacy in accordance with the candidate privacy notice, which can be consulted at Candidate Privacy Notice. Among the information you provide for this purpose, you may choose to give us personal data that will help ensure an inclusive selection process. Rest assured that your information will be treated with the utmost confidentiality, in compliance with applicable regulations, and will not be available to hiring managers or anyone outside the recruitment team. Help us maintain, together, an inclusive and welcoming environment. By submitting information, I confirm that I agree that it will be processed in accordance with the stated privacy notice. 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. Find more about life at GSK at www.gsk.com We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.

Responsibilities

The specialist will prepare, submit, and maintain marketing authorization dossiers for GSK products in Mexico while ensuring compliance with COFEPRIS regulations. They will also coordinate cross-functional inputs and provide regulatory advice to support lifecycle strategies and risk mitigation.