Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

• Location: Bogotá, Colombia or Buenos Aires, Argentina

About the job

Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. As Regulatory Affairs Coordinator within our Regulatory Affairs Team, you'll be responsible for the preparation and elaboration of the dossiers to comply with the regional strategic plan and the maintenance of the marketing authorizations for the products on the market.

Main responsibilities:

• To undertake all necessary dossier elaboration, evaluation and timely dispatch for regulatory submission in accordance with local regulations with agreed business priorities, to ensure compliance of all assigned products
• To assist with the development of optimal regulatory strategies in collaboration with key internal stakeholders to drive submission and approvals in accordance with agreed business priorities
• Keep up-to-date with developments in regulatory affairs and assist with implementation of any required revisions to systems and processes
• Ensure the quality of final dossiers sent, after considering TRT (thoughtful risk taking) approach with full alignment with the country
• Keep track of planned dispatches/renewals and variations, provide support for deviations
• Provide accurate and timely information to ensure regulatory database is update

About you

• Experience: Previous experience in the pharmaceutical sector and regulatory affairs
• Soft skills: Strategic thinking, result orientation and people leadership
• Technical skills: Veeva knowledge
• Languages: Intermediate English level

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
• You'll be part of a truly diverse cross-cultural team and can have real business impact.
• Flexible working policies, including up to 50% remote work.
• Private medical care, life and health insurance, and gender-neutral paid parental leave
• Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.

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!

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