Regulatory Affairs Sr. Analyst

3 semanas atrás

São Paulo, Brasil Novo Nordisk AS Tempo inteiro

 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.

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