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  • Regulatory Affairs Analyst Brazil
  • Novo Nordisk in Brazil, , Brazil
  • jobs
  • 1 week ago

jobs description

Are you detail-oriented and passionate about ensuring regulatory compliance? Do you have experience in compiling and submitting regulatory documents? We are looking for a Regulatory Affairs Analyst to join our team in the Regulatory Affairs department at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a life-changing career.

The Position

As the Regulatory Affairs Analyst you will provide assistance in compiling, submitting, and obtaining approval for New Drug Application (NDA) and Life Cycle Management (LCM) licenses under the supervision of the RA Coordinator. Monitor the local regulatory environment to ensure compliance. Develop local labeling and ensure regulatory compliance in promotional materials. This position is to work in São Paulo, SP.

Your responsabilities includes:
• Monitor local regulatory environment, maintain records, conduct research on submission requirements, and draft... routine correspondence to regulatory agencies.
• Assist in monitoring project timelines, provide information on local regulatory requirements to other departments, and establish open communication with other departments.
• Support compiling, submitting, and approving NDA and LCM licenses, manage regulatory documents, and ensure compliance with HA requirements.
• Review documents required for submissions, prepare application forms, and support approval and post-approval activities.
• Monitor applications during HA evaluation, answer questions from the HA, and update document archival systems.
• Support in developing, reviewing, and updating labeling material, ensure legal compliance with HA's requirements, and control the quality of translations.

Qualifications
• You hold a Bachelor's degree in Pharmacy.
• This person is expected to have fluent oral and written English.
• It's desirable that the candidate have experience with regulatory authorities or at an international pharmaceutical manufacturer.
• Having experience in healthcare products would be an advantage.

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 55,000 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 March 31st, 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
Brazil

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