Regulatory Affairs Analyst

Are you passionate about regulatory compliance? Do you want to play a crucial role in ensuring the licence to operate in Argentina? We are looking for a dedicated Regulatory Affairs Analyst to join our team in Argentina. If you are ready to make a difference, read more and apply today for a life-changing career. 

The Position 

As a Regulatory Affairs Analyst at Novo Nordisk, you will: 

• Manage the compilation, preparation, and submission of importation letters in compliance with local legislation, ensuring prompt follow-up and immediate notification. 

• Ensure compliance and timely submissions by assessing registration files, handling HA queries, coordinating document translations, and submitting variations in collaboration with key stakeholders. 

• Maintain regulatory compliance and documentation by managing renewals, lifecycle management (LCM) activities, and archiving. 

• Manage labelling compliance and updates by developing, reviewing, and updating materials. 

• Monitor the regulatory environment and inform when applicable, the impacted areas within the organization. 

Qualifications 

We are looking for candidates with the following qualifications: 

• University degree in Pharmacy or pharmaceutical-related studies in progress. 

• Minimum 1 year of experience in the pharmaceutical industry. 

• Knowledge of local legislation.  

• Preferred experience with biological products. 

• Fluent in oral and written English. 

About the Department 

Join our dynamic and professional team in Argentina, where we are dedicated to ensuring regulatory compliance and licence to operate. Our department covers Regulatory Affairs, Quality, Pharmacovigilance & Quality Control laboratory. 

We work collaboratively to shape future regulatory frameworks and ensure our products meet the highest standards. With a focus on innovation and patient safety, our team is committed to making a positive impact on the lives of patients worldwide. 

Working at Novo Nordisk  

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. 

Contact  

To complete your application, please click in "Apply now" attach your CV and follow de instructions. For more information, please follow us on LinkedIn: Novo Nordisk: About | LinkedIn 

Deadline  

Apply before March 7th 2025. 

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.  

Together, we’re life changing.