Job title: Regulatory Affairs Junior Analyst
- Location: São Paulo - SP
- Tipo de trabalho: Vaga de Prazo Determinado (09 meses)
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Regulatory Affairs Team for Brazilian Market as a Regulatory Affairs Junior Analyst and you'll play a crucial role in managing pharmaceutical product registrations and maintaining marketing authorizations by preparing and submitting comprehensive dossiers for new registrations, post-approval changes, and site registrations/renewals ensuring compliance with regional strategic plans and regulatory requirements.
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We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
- Develop and maintain strong relationships with global regulatory platforms and local partners to ensure operational excellence and effective stakeholder support.
- Stay informed about regulatory changes through collaboration with local partners, assessing impacts and implementing necessary follow-up actions.
- Prepare, evaluate, and dispatch regulatory submission dossiers in compliance with local regulations and business priorities for assigned products.
- Collaborate with key internal stakeholders to develop optimal regulatory strategies, driving submissions and approvals in line with business goals.
- Manage responses to health authority inquiries, coordinating timely and thorough replies in accordance with local requirements.
- Track planned submissions, renewals, and variations, providing support for any deviations and ensuring accurate database updates.
- Ensure timely dispatch, tracking, and archiving of dossiers to responsible affiliates, while maintaining up-to-date records in global database.
• Maintain knowledge of and comply with the principles of Ethics and Integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market.
• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies, with the aim of preventing accidents, avoiding health risks, promoting employee well-being and reducing environmental impacts resulting from the execution of work activities.
• Support Sanofi Diversity & Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities.
About you
- Experience: Experience in the pharmaceutical or healthcare sector, with a focus on regulatory affairs will be a differential.
- Soft and technical skills: Knowledge of regulatory requirements for variations, renewals, and labelling in Brazil.Good writing, presentation, and communication skills, with the ability to influence and build relationships across teams.
- Education: Educational background in health sciences, life sciences, or regulatory affairs (e.g., Pharmacy, Biochemistry, Chemistry, or related scientific field).
- Languages: Portuguese (Brazil) and good working knowledge of English
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks' gender-neutral parental leave.
Pursue Progress. Discover Extraordinary.
Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Attention to the Phrases Below
*Always aimed at the safety and well-being of our employees, proof of COVID-19 vaccination is an essential item for all employees, being present on the list of admission documents.
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