Analista de Assuntos Regulatórios

Regulatory Affairs Senior Analyst

• Local: São Paulo
• Fixed term contract

About the job

The Regulatory Affairs Senior Analyst is responsible for providing regulatory expertise and support for pharmaceutical/healthcare products throughout their lifecycle, ensuring compliance with local and international regulations.

Main responsibilities & accountabilities

• Prepare and submit regulatory documentation to health authorities;
• Monitor and interpret regulatory requirements and guidelines;
• Coordinate with cross-functional teams (Quality, Manufacturing, R&D);
• Manage product registrations and maintain regulatory databases;
• Support safety labeling implementation and monitoring;
• Provide regulatory input on product development strategies;
• Ensure compliance with applicable regulations and company policies;
• Participate in regulatory agency interactions;
• Support regulatory data collection and validation activities;
• Maintain knowledge of and comply with Sanofi's Ethics and Integrity principles, company policies, and codes of conduct governing the pharmaceutical industry;
• Comply with and promote Sanofi's Health, Safety, and Environment (HSE) policies, aiming to prevent accidents, reduce health risks, promote employee well-being, and minimize environmental impacts resulting from work activities;
• Support Sanofi’s Diversity and Inclusion strategy and initiatives to ensure that all employees and partners are treated with respect and provided with equal opportunities.

About you

Academic Background: Bachelor's degree in Life Sciences, Pharmacy, or related field.

Experience

• Experience in regulatory affairs.
• Knowledge of pharmaceutical regulations and submission requirements.

Languages:  English Intermediate

Soft Skills

• Strong analytical and problem-solving skills;
• Excellent communication and project management abilities;
• Attention to detail and ability to manage multiple priorities

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.

This role is critical to our team’s success and offers exposure to a broad range of activities within the lab. For an ambitious microbiologist, it’s a chance to gain lots of experience, fast.

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 videoand check out our Diversity Equity and Inclusion actions atsanofi.com!

Attention to the Phrases Below

* Lead Candidate Identified - On behalf of transparency, we would like to inform you that for this position there is a preferred candidate identified.

*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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