Shire Jobs

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

#LI-LAT #LI-Hybrid

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)