Regulatory Affairs Sr. Analyst

  Are you passionate about ensuring regulatory compliance for pharmaceutical products? Do you have experience in regulatory affairs and a strong understanding of the submission process? We are looking for a Regulatory Affairs Sr. Analyst to join our team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the pharmaceutical industry, read on and apply today for a life-changing career.

The Position

As a Regulatory Affairs Sr. Analyst (Synthetic Products) at Novo Nordisk, you'll lead the regulatory approval process for synthetic molecules, collaborating on NDA and LCM licenses while actively participating in discussions to address regulatory needs. Your responsibilities include ensuring compliance, serving as a regulatory liaison, and contributing to team efforts. The ideal candidate possesses a strong regulatory background, excellent communication skills, and the ability to work collaboratively.This position is to work in São Paulo, SP.

Your responsabilities includes:

• Spearhead the development and expertise in synthetic molecules category, contributing to internal and HQ discussions for implementing synthetic products in Brazil.
• Actively engage in discussions and share insights on the synthetic environment, staying abreast of legislation, regulations, and guidelines.
• Conduct thorough research on submission requirements, monitor project timelines, and provide crucial regulatory information to other departments and Business Areas.
• Manage regulatory archiving in compliance with local legislation and SOPs, fostering open communication and cooperation with cross-functional departments.
• Support the compilation, submission, and approval of NDA and LCM licenses, ensuring timely provision of product information for tender submissions.
• Oversee the preparation of regulatory documents, technical files, and labelling materials, adhering to local legislation and SOPs, while ensuring compliance with HA requirements and addressing post-approval commitments.

Qualifications

• You hold a Bachelor’s degree in Pharmacy or related areas.
• This person is expected to have fluent oral and written English.
• We would like to see your previous experience with synthetic molecules products.
• It’s desirable that the candidate have at least 2 years’ experience with regulatory authorities or at an international pharmaceutical manufacturer.

About the Department

The Regulatory Affairs Department at Novo Nordisk plays a crucial role in ensuring regulatory compliance for new products and product amendments. Our team works closely with health authorities and policymakers to shape future regulatory frameworks. We are dedicated to gaining regulatory approval for clinical trial applications, new drugs, devices, and digital health solutions. Additionally, we are responsible for monitoring the safety of our products and taking appropriate actions if safety issues arise. By joining our department, you will have the opportunity to make a difference in the lives of patients and contribute to the success of our organization. Novo Nordisk is currently the market leader in Diabetes, Obesity and Growth Hormone. We are one of the fastest growing companies in Brazil for 3 years and we expect to continue achieving double-digit growth in the coming years.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 64,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.

Contact  

To complete your application, please submit your CV by clicking "Apply now" and following the instructions. For more details, follow our LinkedIn page: Novo Nordisk: About | LinkedIn  

Deadline

Apply before May 19th, 2024.

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.