Regulatory Affairs Sr. Analyst (Synthetic products)
**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:São Paulo, São Paulo, BR-
**The Position**- 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.
**About the Department**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**
**Deadline**
- 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.