Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

Category: Reg Affairs & Safety Pharmacovigilance

Location:Ciudad de México, Ciudad de México, MX

Regulatory Affairs

Mexico City, Mexico

Are you passionate about regulatory compliance and ensuring patient safety? Do you have experience navigating complex regulatory landscapes and working with global stakeholders? If so, we invite you to join our team as a Regulatory Affairs Coordinator in Mexico City. Apply today and make a difference in the lives of patients worldwide

Your new role

As a Regulatory Affairs Coordinator, you will:

• Lead the regulatory strategy for complex projects, including molecule launches and major changes (e.g., new warehouse).
• Act as a strategic liaison between Regulatory Technical areas and Commercial areas (Marketing, Market Access).
• Prepare, review, and submit high-quality technical dossiers (e.g., dossiers, variations) to the health authority (COFEPRIS).
• Manage the regulatory strategy for biotechnology products, including participation in the New Molecules Committee (CMN).
• Ensure the management and regulatory compliance of all labelling processes at the national level.
• Maintain fluid and advanced technical and business communication with global stakeholders, using English as the primary language.
• Apply Project Management and Agile principles to manage multiple complex projects and ensure compliance with regulatory deadlines.

Your new department

The Regulatory Affairs department in Mexico City plays a vital role in ensuring regulatory compliance for new products and product amendments, safeguarding our license to operate. Our team is responsible for gaining regulatory approval for clinical trial applications, new drugs, devices, and digital health solutions, as well as expanding the availability of existing products. We also engage in shaping future regulatory frameworks through dialogues and negotiations with health authorities and policymakers.

Our department is dynamic and collaborative, with a strong focus on delivering high-quality results to ensure patient safety and compliance. By joining us, you will have the opportunity to work in a fast-paced and innovative environment, making a meaningful impact on the lives of patients in Mexico and beyond.

Your skills and qualifications

We are looking for a candidate with the following qualifications:

• Must-Have Skills
• 2 to 8 years of experience in Regulatory Affairs, acquired exclusively in multinational pharmaceutical companies (Big Pharma).
• Advanced English proficiency (B2-C1) for global technical and business communication.
• Bachelor's degree in Pharmaceutical Chemistry, Pharmaceutical Engineering, Biotechnology, Biochemistry, or a related field.
• Direct experience in submitting dossiers to COFEPRIS, handle communications to COFEPRIS and managing labelling processes.
• Demonstrable experience with biotechnology products and participation in the New Molecules Committee (CMN).
• Proven ability in stakeholder coordination and experience in formal project management
• Ability to communicate complex information in a simpler and executive manner
• Nice-to-Have Skills
• Project Management (PM) certification or prior experience in People Management or Artificial Intelligence (AI).

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information

For more information, visit , Facebook, Instagram, X, LinkedIn and YouTube.

To complete your application, click on "Apply now", attach your CV and follow the instructions.

Deadline

Please apply before November 20th, 2025

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.