Job title: Regulatory Affairs Senior Associate

• Location: Bogotá, Colombia
• Hybrid working model
• Job type: Permanent

About the job

Our Team:

Regulatory Affairs area stands at the extraordinary confluence of science and technology, ensuring key discoveries and advancements are delivered to benefit society seamlessly. As a cornerstone of Sanofi's transformation in healthcare, our mission is to enable access to medications people need years sooner while maintaining the highest standards of safety and compliance.

In Latam our area operates across 21 regulated countries (3 Key Markets: Mexico / Argentina & Colombia). Our role at Sanofi has evolved beyond traditional enforcement to become a strategic thought partner and engine of innovation. We leverage cutting-edge technologies, including AI and "bionic" teams, to support R&D and accelerate the delivery of life-changing medicines.

Main responsibilities:

• Develop and execute regulatory strategies for assigned products aligned with commercial priorities, global standards, and business unit strategic plans, acting as a strategic thought partner.
• Manage end-to-end regulatory submissions to health authorities including new product registrations, renewals, post-approval variations, and promotional materials, with mandatory direct experience working with INVIMA in Colombia.
• Lead regulatory processes for biological medicines and orphan disease products, including registration, variations, and maintenance of health authorizations.
• Build and maintain strategic relationships with health authorities through direct interaction, meetings, public consultations, and active participation in pharmaceutical chambers and regulatory working groups.
• Collaborate cross-functionally with Quality, Pharmacovigilance, Medical, Marketing, Supply Chain, Market Access, Public Affairs, and Global Regulatory Affairs (GRA) teams, ensuring "One Sanofi" alignment.
• Proactively monitor the regulatory environment, analyze regulatory changes, track competitor developments, and communicate updates to influence business strategies and ensure compliance.
• Maintain accurate and up-to-date product information in global electronic systems (Veeva Vault RIM, Qualipso, 4M PromoMats, OnePack, VistaLink) and ensure compliance of promotional and non-promotional materials with local regulations.
• Identify and implement regulatory process improvements, manage projects autonomously, support product crisis management (shortages, recalls, counterfeits), and contribute to the transformation of Regulatory Affairs as an engine of innovation.

About you

Experience:

• Proven track record in Regulatory Affairs within the pharmaceutical industry.
• Mandatory direct experience working with INVIMA in Colombia.
• Mandatory experience in regulatory processes for biological medicines and orphan disease products (registration, variations, and health authorization maintenance).
• Experience managing end-to-end regulatory submissions: new product registrations, renewals, and post-approval variations.
• Experience building and maintaining relationships with health authorities.
• Project management experience in regulatory affairs.
• Regional Experience across LATAM/COPAC countries is a plus.

Soft skills:

• High level of autonomy and self-management in decision-making.
• Excellent communication skills (verbal and written).
• Strategic thinking and results orientation.
• Strong relationship building and influence capabilities.
• High level of cross-functional collaboration.
• Open-mindedness and cultural adaptability.
• Ability to manage multiple priorities simultaneously.

Technical skills:

• Knowledge of regulatory filing systems and GxP compliance.
• Proficiency in global electronic systems (Veeva Vault RIM, Qualipso, 4M PromoMats, OnePack, VistaLink).
• Understanding of pharmaceutical regulations and technical requirements for biological medicines and orphan disease products.
• Regulatory intelligence and environment monitoring capabilities.
• Document management and submission processes expertise.

Education:

• Pharmaceutical Professional (Chemist/Pharmacist) — Mandatory.

Languages:

• English: Advanced.

#LI-Hybrid

#LI-LAT

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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!