Senior Medical Regulatory Writer

• Location: Bogotá, Colombia

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Medical Regulatory Writer within our Global Medical Services Team, you’ll be responsible for delivering high‑quality medical documents on time and in compliance with internal and external standards and guidelines.

Main responsibilities:

• Deliver high‑quality medical and regulatory documents (PBRER, ACO, CSR, ID Cards, clinical evaluation reports, product alerts, trial transparency documents, etc.) on time and in full compliance with all standards and timelines.
• Participate independently in planning analyses and data presentations, ensuring high scientific and regulatory accuracy.
• Develop and maintain deep Therapeutic Area (TA) expertise to support content quality and scientific rigor.
• Review and provide constructive feedback on documents prepared by peer writers, ensuring consistency and excellence.
• Collaborate effectively with global and local partners across Scientific Communications, Medical/Regulatory Writing, Pharmacovigilance, Regulatory Affairs and Corporate Affairs.
• Build strong relationships with medical and pharmacovigilance stakeholders and mentor junior writers by sharing knowledge and expertise.
• Ensure process excellence by authoring, reviewing, and maintaining regulatory‑compliant content, managing product alert documentation, tracking postings, and ensuring audit/inspection readiness.

About you

• Experience: Previous experience in regulatory writing for the pharmaceuticals/healthcare industry
• Soft skills: Stakeholder management, communication skills and ability to work independently/within a team environment
• Technical skills: Excellent writing and editing skills, with experience in data retrieval, scientific data interpretation, medical literature screening, and a strong understanding of ICH and GCP/GVP standards
• Education: Degree in life sciences
• Languages: Advanced 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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#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 and check out our Diversity Equity and Inclusion actions at sanofi.com!