Regulatory Submission Lead - Submission Delivery Excellence, LCM

GSK; Ciudad de México; Presencial; MXN 60,000 - 100,000; Jornada completa

Descripción de la vacante

A global biopharma company based in Ciudad de México is searching for a Submission Lead to oversee the regulatory submission process. This position involves collaborating closely with cross-functional teams to ensure compliance and the timely delivery of submissions. Candidates should possess a relevant Bachelor's degree, be fluent in English and Spanish, and exhibit strong organizational skills. Join us in our mission to positively impact the health of millions across the globe.

Formación

• Candidates must have a Bachelor's degree in a relevant field.
• Understanding of regulatory submission requirements is essential.
• Fluent in both English and Spanish.

Responsabilidades

• Lead regulatory submissions ensuring compliance with requirements.
• Collaborate with teams to compile and review submission packages.
• Monitor regulatory changes and guide internal teams accordingly.

Conocimientos

Detail-oriented

Proactive

Strong communication in English and Spanish

Ability to manage multiple tasks

Attention to detail

Educación

Bachelor’s degree in pharmacy, chemistry, biotechnology, or a related field

Herramientas

Veeva Vault

Descripción del empleo

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.
Find out more: Our approach to R&D

Position Summary

Are you ready to make a meaningful impact in a dynamic regulatory role? As a Submission Lead in Submission Delivery Excellence, Lifecycle Management, you will play a key role in ensuring the timely and high-quality delivery of regulatory submissions. You’ll collaborate with cross-functional teams to support the lifecycle management of pharmaceutical products, helping us get ahead of disease together. We value candidates who are detail-oriented, proactive, and skilled at building relationships across teams. This role offers opportunities for growth, learning, and contributing to a mission that improves lives worldwide.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Coordinate and deliver regulatory submissions, ensuring compliance with global and local requirements.
• Collaborate with cross-functional teams to compile and review submission packages, including Chemistry, Manufacturing, and Controls (CMC) documentation.
• Author and review LOC MSRs prepared in Spanish, ensuring accuracy and compliance with regulatory standards.
• Monitor regulatory changes and provide guidance to internal teams on evolving requirements.
• Support audits and inspections, ensuring adherence to regulatory and company standards.
• Identify opportunities for process improvements and contribute to optimizing regulatory workflows.
• Build and maintain strong relationships with internal and external stakeholders to ensure smooth regulatory processes.

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in pharmacy, chemistry, biotechnology, or a related field.
• Strong understanding of regulatory submission requirements and lifecycle management processes.
• Ability to author and review LOC MSRs prepared in Spanish.
• Excellent written and verbal communication skills in English and Spanish.
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Attention to detail and commitment to delivering high-quality work.

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Master’s degree in regulatory affairs, pharmacy, or a related field.
• Experience working in a matrixed, international environment.
• Familiarity with regulatory systems such as Veeva Vault or similar platforms.
• Knowledge of global regulatory requirements, including EU and US markets.
• Strong interpersonal skills and ability to collaborate effectively across teams.
• Demonstrated ability to engage and influence senior stakeholders.

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.

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