Regulatory Affairs Manager

Job title: Regulatory Affairs Manager

• 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 in Brazil and you will be part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health Authorities & external partners worldwide. Innovative ways of working, digital mindset and data driven decision making are the fundamentals of our strategy.  In Brazil we are part of an International team, working on regulatory solutions to enable business needs. We are a team engaged in strengthening the regulatory environment to support access to innovative therapies to Brazilian citizens. We work in partnership with all our internal and external stakeholders to increase our impact in the Brazilian health system.

Main responsibilities:

• Ensure the implementation of regulatory strategies and projects to obtain marketing authorization for new products and existing portfolio, having as ultimate goal regulatory compliant products to be commercialized according to business strategy.
• Responsible to interact with all the appropriate stakeholders to ensure compliance of the products according to local regulatory requirements and Sanofi policies.
• In alignment with the regulatory country Head represents the company at the Regulatory Health Agency and concerned pharma associations.
• Ensures regulatory environment and requirements are well understood and considered in product business strategies.
• Develop relations with key regulatory authorities in Brazil; discuss issues and find solutions in the best interests of company.
• Manages multifunctional team to support business needs within the different business units: Promo and non-promo material approval, product strategies (new products and LCM) discussion and implementation, regulatory input – trends and competitors intelligence – in Brand teams
• Develop and execute policy strategies to advance Sanofi goals and Brazilian Ecosystem

• 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 in managing directly and/or indirectly regulatory affairs teams

• Good Strong interpersonal, influencing and communication skills
• Ability to build partnerships internally and externally
• Analytical and critical thinking
• Business Accumen
• English is a must
• Training in the health area, previous experience in regulatory affairs is a plus;
• Ability to work in matrix, local and global teams
• Autonomy in decision-making
• Understanding of the Brazilian health environment is also a differential

Why choose us?

The regulatory affairs team at sanofi is a team that connects different internal and external areas and has been following market trends, learning about data-driven decision-making and curious to contribute with artificial intelligence tools to support and facilitate their activities.

We work in an inclusive environment and are ready to try new ways of working with internal and external stakeholders.

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.

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