Regulatory Affairs Analyst

1 semana atrás

Sao Paulo, Brasil Novo Nordisk Tempo inteiro

Regulatory Affairs Analyst (Clinical Trials)

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:São Paulo, São Paulo, BR-
**The Position**- Your responsabilities includes:
- Develop Informed Consent Forms and regulatory dossiers for initial submissions, amendments, and notifications.
- Manage the submission and approval process for trial dossiers, amendments, and notifications.
- Handle safety information, including submission of SUSARs, distribution of safety documents, and management of adverse event reports.
- Coordinate importation processes for clinical supplies and lab kits, including payment coordination and invoice release; also maintain the Clinical Trial Management System and regulatory documentation up to date.

**Qualifications**
- You hold a Bachelor's degree in health-related areas (e.g., Medicine, Pharmacy, Biology, Biomedicine).
- This person is expected to have Advanced level of English.
- We’d like to see that you demonstrate full understanding of international and local regulations on Clinical Trials.

**About the Department**
- We have a very collaborative, knowledge-sharing, and inclusive culture in Regulatory Affairs. It fits our vibrant, informal, and curious atmosphere perfectly. And combined with our critically analytical mindsets, intelligent use of technology, and our bold, innovative thinking, we achieve a great overview and a deep understanding of every step of the entire process. Our approach, culture and ways of working empower us to develop and grow as individuals and to improve and optimise our processes as a team - making our work and efforts valuable and impactful to both Novo Nordisk and the lives of our patients worldwide. 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**

**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.

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