Job Description

Clinical Development Center
Mexico City

Are you passionate about clinical trials and regulatory submissions? Do you want to play a key role in ensuring high-quality execution of study start-up activities? If so, we are looking for a Start-Up Specialist to join our team and make a difference. Read more and apply today!

Your new role
As a Start-Up Specialist at Novo Nordisk, you will lead, coordinate, and manage the execution of start-up activities for assigned trials. Your responsibilities will include:

• Prepare, review, and submit Health Authority (HA) and Ethics Committee (EC) dossiers in compliance with ICH GCP regulations and local requirements.
• Develop regulatory strategies and start-up plans in collaboration with trial teams and SSU Managers.
• Perform quality control and ensure timely site activation by managing essential documents and training plans.
• Engage with cross-functional teams, clinical sites, and external stakeholders to ensure alignment and timely delivery of start-up and submission activities.
• Provide local regulatory insights and support continuous improvement initiatives related to study start-up and compliance.
• Ensure adherence to ICH GCP, regulatory requirements, and internal SOPs while contributing to inspection readiness and audits.

Your new department
As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.

You will be part of the Clinical Development team, where we strive to deliver high-quality clinical trials that make a difference for patients worldwide. The department operates in a fast-paced and dynamic environment, fostering collaboration and innovation. Based at Mexico City, you will join a global team dedicated to driving excellence in clinical development and regulatory submissions. Together, we aim to ensure efficient trial initiation and regulatory compliance while maintaining a supportive and engaging atmosphere.

Your Skills and Qualifications
Need to have:

• A bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
• 3+ years of experience in clinical trials, regulatory affairs, or submission management.
• Extensive experience in regulatory submissions and a thorough understanding of global clinical trial application processes.
• Advanced English
  Nice to have:
• Proficiency using Veeva software.

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 February 12th, 2026

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

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 preventing 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.