About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, oncology, and inflammatory diseases. Our innovative therapies have transformed lives, ensuring access to cutting-edge treatments across the globe. With a relentless drive for scientific innovation, Gilead fosters collaboration and determination among its teams to address global health challenges head-on.

At Gilead, every employee plays a pivotal role in discovering and developing life-changing medicines. We are committed to bold ambitions, supported by a culture where people leaders drive inclusion, development, and empowerment. Joining Gilead means contributing to therapies that combat HIV through antiviral advancements, tackle oncology with targeted cancer treatments, and address inflammatory diseases with novel immunomodulators.

Role Overview

The Manager, Regulatory Affairs position at Gilead Sciences in Mexico City, Mexico, is a critical leadership role within our global regulatory team. This full-time opportunity involves coordinating regulatory submissions for distributor countries, with a primary focus on Mexican requirements. You will manage complex submissions including CMC variations, labeling updates, and renewals, while providing expert guidance to cross-functional teams.

Working under minimal supervision from senior professionals, you will ensure compliance with local and regional regulations across Mexico, Colombia, Argentina, Chile, and Uruguay. This role demands excellent organizational skills to juggle multiple projects with tight timelines, alongside strong verbal and written communication. Ideal candidates bring passion for regulatory excellence and a desire to impact Gilead's mission in HIV, oncology, and inflammatory diseases.

Key Responsibilities

As Manager, Regulatory Affairs, your core duties include:

• Coordinating regulatory submissions to distributor countries and preparing dossiers under Mexican regulatory requirements.
• Managing submissions for CMC variations, labeling updates, and product renewals.
• Providing regulatory expertise on labeling changes and supporting submission teams on specified projects.
• Contributing input to senior professionals for country-specific labeling strategies.
• Ensuring product packaging and information align with product licenses.
• Participating in group meetings, local, and global product submission teams, presenting project status and strategies.
• Initiating or contributing to process improvements impacting Regulatory Affairs and other departments.
• Pursuing self-development to acquire essential regulatory skills and knowledge.

Qualifications & Requirements

To succeed in this role, candidates should possess:

• 10+ years of experience in Regulatory Affairs or relevant industry experience.
• A degree in a scientific field is preferred.
• In-depth knowledge of regulatory requirements in Mexico, with familiarity in Colombia, Argentina, Chile, and Uruguay.
• Excellent organizational skills to manage multiple projects with tight deadlines.
• Superior verbal, written communication, and interpersonal skills.
• Ability to work independently with minimal direction from senior professionals.

This position is ideal for seasoned regulatory experts eager to apply their expertise in a dynamic biopharmaceutical environment focused on high-impact therapies.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional success:

• Competitive salary estimated at $90,000 - $150,000 USD annually, reflecting biopharmaceutical sector rates in Mexico City with a buffer for top talent.
• Comprehensive health insurance, including medical, dental, and vision coverage.
• Retirement savings plans with company matching.
• Generous paid time off, parental leave, and flexible working arrangements.
• Professional development programs, tuition reimbursement, and leadership training.
• Employee wellness initiatives, including fitness reimbursements and mental health support.
• Stock purchase plans and performance-based incentives.

Career Growth

Gilead invests heavily in employee development, positioning you for long-term success. As a Manager, Regulatory Affairs, you will gain exposure to global projects, enhancing your expertise in LATAM regulations. Our people leaders mentor and empower teams, opening doors to senior roles in regulatory strategy, compliance, or international operations. With Gilead's growth in HIV, oncology, and inflammatory diseases, your contributions will accelerate your career trajectory in a collaborative, innovative culture.

Development Opportunities

Access tailored training, cross-functional projects, and leadership programs. Network with global experts and influence process improvements that shape Gilead's regulatory landscape.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven organization where your work directly improves lives. We tackle HIV with groundbreaking antivirals, advance oncology through precision medicines, and innovate in inflammatory diseases to reduce patient suffering. In Mexico City, you'll collaborate with diverse teams in a vibrant hub, enjoying a premium work environment that values inclusion and impact. Gilead's commitment to employee aspirations ensures you thrive while making a difference.

Role FAQs

What is the experience level required?

10+ years in Regulatory Affairs or equivalent, with strong Mexico regulatory knowledge.

Is relocation assistance provided?

Gilead supports internal mobility; external candidates should inquire during application.

What diseases does Gilead focus on?

Key areas include HIV, viral hepatitis, oncology, COVID-19, and inflammatory diseases.

How does this role contribute to Gilead's mission?

By ensuring regulatory compliance, you enable timely access to life-changing therapies globally.

Is this a remote position?

This is an on-site role in Mexico City, Mexico.

Apply now to join Gilead Sciences and help create a healthier future.