Regulatory Affairs Specialist

Do you have experience working with biologics and supporting the introduction of new treatments to the market? Would you like to be part of a dynamic team and make it possible to introduce innovative biological molecules for the first time in the country? Join us and be part of this exciting challenge! We are looking for a Regulatory Affairs Specialist to join our team in Chile. The position provides you the opportunity to work in a high performing team to contribute directly towards the business results while creating values for the patients. If that sounds like you, read on and apply today for a life-changing career.

The Position

As a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for all registration activities related to new drugs applications, new therapeutics indications, and product life cycle management, including review and approval of promotional materials. You will work with regulatory colleagues and other stakeholders to proactively seek opportunities and solutions to challenges. You will be reporting directly to Regulatory Affairs Manager & Technical director.

You will also:

• Identify the best regulatory pathways and timelines for submission. Communicate and assess global strategies while collaborating with business units to define local approaches.
• Compiling, submitting, and implementing the approval of NDA and LCM, ensuring compliance with regulatory requirements, and handling queries from health authority.
• Participate in the labelling process: creation/update/review/approval and proofreading of packaging materials in the Lift system, according to local legislation and global SOPs.
• Ensure full compliance with Novo Nordisk and local Health authority requirements.
• Assume the technical direction of Novo Nordisk in the absence of the technical director (as backup).

Qualifications

We realize that few people are experts at everything. But if you can nod your head at the following attributes then you could be the person we are looking for:

• University degree in Pharmacy (degree validated in Chile).
• Minimum 4 years’ experience in the Regulatory Affairs area for the pharmaceutical industry.
• Experience in registration and/or modifications of biotechnological products, including management of the GICONA regulatory platform.
• Experience with regulatory systems and packaging material management is desirable.
• Fluent in oral and written English.

Additionally, to be successful in this role, you should have:

• Excellent attention to details while working on multiple tasks
• Ability to work effectively with cross-functional teams, to ensure regulatory compliance and delivering excellent performance and results
• Flexibility to adapt to changing regulatory environments and requirements, ensuring continuous compliance and successful product lifecycle management

About the Department

You will join our team in Chile, where we focus on ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. Our department is responsible for gaining regulatory approval of new drugs and devices, and digital health, as well as expanding the availability of existing products. We shape future regulatory frameworks through dialogues and negotiations with health authorities and policymakers. Our team is dynamic, collaborative, and dedicated to safeguarding patients and ensuring medicines are safe to use.

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 66,000 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 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 February 9^th 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.