R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt

Regulatory Affairs Analyst – Mid-Level

• Location: São Paulo - SP

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 as Regulatory Affairs Analyst and you’ll be responsible for regulatory activities, focusing on managing Clinical Trials Applications and company's portfolio maintenance.

Main responsibilities:

• Regulatory Submissions & Portfolio Management - Evaluate, prepare, and submit New Marketing Applications (NMA), Lifecycle Management (LFM) and Good Manufacturing Practices Certificate (GMPc) submissions of medicinal products to Brazilian Health Authority. Develop optimal regulatory strategies, in collaboration with key internal stakeholders.

• Clinical Trials Application (CTA) - Define the strategy, prepare and ensure that the regulatory dossiers related to Clinical studies (New initial CTA, Amendments, Notification, DSUR, annual reports) are submitted to the Health Authorities within the stablished timelines.

• Projects - Analyse the feasibility and participate or lead new projects for the implementation of processes in the Regulatory area. Ensure that the company's strategic projects are implemented at an adequate level of adherence to what was previously established by the Organization, providing guidance on legislation, and ensuring that, if necessary, corrective actions are adequately implemented.

• Regulatory Policy - Monitor, know, evaluate, and disseminate new or updated legislation and its impacts on performed activities and/or on the portfolio, as well as company and competitor publications, contributing to Regulatory Intelligence. Ensure proper implementation of new or updated legislation, whenever applicable

• Ad Promo - Analyse and review promotional material, aiming at compliance with current legislation and internal procedures.

• Performance, Data & Digital - Ensure the correct performance of activities and outcomes for the regulatory processes being performed under their responsibility and/or accountability, including the correct and timely data entry of records in local and global databases. Ensure that regulatory area metrics and dashboards are constantly updated through engagement in culture and procedures for this purpose. Support for the development of new systems and improvement in current systems (inputs needed by the area), evaluation of technical specifications and user practice.

• Health, Safety & Environment - Comply with Health, Safety and Environment standards and procedures related to their activities, identify and correct unsafe conditions or behaviours, and immediately report any dangerous situation

• 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: Background in Regulatory Affairs of Pharmaceutical Products and Clinical Trials is essential
• Soft and technical skills: Digital Adoption, Change Agility, Collaborative Communications, Regulatory Strategy, Regulatory Compliance, Data Management, Project Management, Risk Management, Cross Functional Teamwork
• Education: Pharmaceutical Sciences
• Languages: English – Advanced / Fluent – Spanish is a differential

Why choose us?

At Sanofi, we are united by a shared purpose: we chase the miracles of science to improve people's lives. We foster a culture of integrity, respect, and inclusion, where innovation thrives, and every team member's contribution is valued. We believe in empowering our employees, promoting work-life balance, and making a positive impact on global health.

Regulatory Affairs Team is a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with health authorities and external partners worldwide.

PursueProgress. 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.

#LI-LATAM

null

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.