Regulatory Affairs Director – Colombia

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

Reporting directly to the VP Regulatory Affairs Head for Latin America & International, the Regulatory Affairs Director is responsible for leading the regulatory strategy, execution, and governance for GSK’s pharmaceutical and vaccines portfolio in Colombia.

This is a strategic, business-facing, and hands-on leadership role that combines regulatory expertise with operational excellence to enable business growth, accelerate patient access, and ensure full compliance throughout the product lifecycle.

As a trusted advisor to local, regional, and global leadership, the Regulatory Affairs Director partners across the organization and with cross-functional teams to translate business priorities into effective regulatory strategies, leveraging local expertise and regional regulatory perspectives to proactively manage risks and deliver sustainable business outcomes.

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

Key Responsibilities

• Lead the regulatory strategy for Colombia, ensuring successful product registrations, lifecycle management, regulatory compliance, and alignment with local, regional, and global business priorities.

• Represent GSK with health authorities, industry associations, and key external stakeholders, building trusted relationships while proactively influencing the evolving regulatory environment and supporting business objectives.

• Provide strategic regulatory leadership while remaining actively involved in critical submissions, complex regulatory negotiations, regulatory risk assessments, and key business initiatives requiring a hands-on approach.

• Partner across the organization and with cross-functional teams to enable product launches, portfolio optimization, business continuity, and accelerated patient access, ensuring regulatory strategies are aligned with business priorities.

• Anticipate changes in the regulatory landscape, assess business impact, identify risks and opportunities, and develop proactive regulatory strategies that support sustainable growth.

• Drive operational excellence by optimizing regulatory processes, strengthening governance, ensuring inspection readiness, and implementing digital solutions and global best practices.

• Build, coach, and develop a high-performing Regulatory Affairs team, fostering a culture of accountability, collaboration, innovation, continuous improvement, inclusion, and compliance.

Why You?

We are looking for leaders who are passionate about making an impact and enabling innovation that improves patients’ lives.

You will bring strategic thinking, strong regulatory expertise, and the ability to influence across complex organizations while balancing business priorities, regulatory requirements, and patient needs.

Basic Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Medicine, Life Sciences, or another relevant scientific discipline.

• Significant leadership experience in Regulatory Affairs within the pharmaceutical, biotechnology, vaccines, or healthcare industry.

• Proven experience developing and executing regulatory strategies, managing product registrations, lifecycle management activities, and ensuring regulatory compliance for innovative healthcare products, including experience with oncology products.

• Demonstrated experience partnering with health authorities and leading cross-functional initiatives within local, regional, and global matrix organizations.

• Experience working in a regional Regulatory Affairs role as director or managing regulatory activities across multiple Latin American markets, with the ability to navigate diverse regulatory environments and collaborate effectively within regional and global organizations.

• Strong strategic thinking, business acumen, stakeholder management, negotiation, and influencing skills, with the ability to balance strategic leadership and hands-on execution.

• Experience leading, developing, and inspiring high-performing teams while driving organizational change and operational excellence.

• Fluent in Spanish and English.

Preferred Qualifications

• MBA or other advanced scientific or business degree.

• Experience supporting innovative medicines, vaccines, oncology, specialty care, or biologics portfolios.

• Strong understanding of Latin American regulatory environments, with experience supporting multiple markets in the region and collaborating with regional and global Regulatory Affairs organizations.

• Experience leading regulatory transformation initiatives, digitalization, process optimization, and continuous improvement programs.

• Demonstrated success influencing senior leaders and external stakeholders within complex matrix organizations.

• Exceptional communication and relationship-building skills, with the ability to translate regulatory strategy into business value.

• Passion for developing talent while fostering an inclusive, collaborative, and patient-focused culture.

Location

This role is based in Bogotá, Colombia, and follows a hybrid working model, with regular office presence and occasional domestic and international travel as required by business needs

Skills

Business Partnerships, Business Resilience, Communication, Digital Fluency, Life Cycle Management, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Product Registrations, Product Risk Management, Regulatory Compliance Management, Regulatory Experience, Regulatory Negotiations, Regulatory Risk, Regulatory Strategies, Regulatory Strategy Development, Resource Management, Stakeholder Management, Strategic Business Planning

 

 

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 adjustments or accommodation during the selection process to better showcase your abilities, please let our team know as soon as we contact you. We're here to support you.

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