Regulatory Affairs Coordinator

Regulatory Affairs Coordinator 
Mexico City, Mexico 

Be the strategic link between breakthrough therapies and the patients who need them in Mexico. In this role, you'll navigate the complex regulatory landscape to bring life-changing treatments to market—from submission strategy to Health Authority approvals. 

Your new role  

As Regulatory Affairs Coordinator, you'll be the driving force behind getting innovative treatments approved and into the hands of Mexican patients. You'll own the entire regulatory lifecycle while building strategic relationships with COFEPRIS and shaping how we approach regulatory excellence in Mexico. 

Your responsibilities will include: 

• Leading all regulatory submissions to Mexican Health Authorities, including NDAs, product variations, renewals, promotional materials, and import licenses 
• Developing and executing regulatory strategies that balance speed-to-market with compliance excellence 
• Planning and conducting regulatory interactions with COFEPRIS, including technical meetings and New Molecules Committee presentations 
• Coordinating regulatory intelligence to assess emerging regulations and competitive landscape, providing risk and impact assessments 
• Maintaining core labelling throughout the product lifecycle and ensuring promotional materials meet both internal and external regulatory standards 
• Acting as the regulatory subject matter expert for cross-functional teams across the Mexican affiliate and collaborating with HQ, International Operations, and LATAM regulatory groups 
• Mentoring colleagues with less experience and contributing to continuous improvement of regulatory processes 

Your new department  

Within our Mexican affiliate located in Mexico City, the Regulatory Affairs team is at the heart of bringing our expanding portfolio to patients across Mexico. You'll work within a dynamic environment where regulatory excellence meets commercial ambition. As we scale up our presence with biotech products, new molecules, and orphan therapies, your expertise will be critical in navigating COFEPRIS requirements while maintaining the highest standards of quality and compliance. You'll collaborate daily with commercial teams, supply chain, and business units locally, while staying connected to our global regulatory network. 

Your skills & qualifications 

We're looking for an experienced regulatory professional who thrives in complexity and sees regulatory challenges as opportunities to innovate. You'll bring: 

• Bachelor's degree in QFB (Químico Farmacéutico Biólogo), QFI, IBT, IBQ, or a related field in pharmaceutical sciences 
• 2-10 years of regulatory affairs experience within a transnational pharmaceutical company, with proven success in managing submissions and Health Authority interactions 
• Deep knowledge of Mexican regulatory requirements, COFEPRIS guidelines, CTD submission format, and ICH requirements for biotech products 
• Experience with biotech products, New Molecules Committee processes, and ideally orphan products 
• Advanced English proficiency (written and spoken) to collaborate effectively with international teams 
• Strong stakeholder management skills, with the ability to influence across functions and build trusted relationships with Health Authorities 
• Results-oriented mindset with excellent communication, presentation, and time management capabilities 

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  novonordisk.com,  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 May 17th 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.