Job Title: Regulatory Affairs Associate
- Location: Bogotá, Colombia
- Work model: hybrid
About the Role
As a Regulatory Affairs Associate you will be responsible for preparing dossiers for LCM variations (CMC, labeling and administrative matters) and renewals, in accordance with local requirements for all product categories, including biologics and vaccines, as well as preparing responses to requests from health authorities (HAQ), following the strategies defined by CRM. You will also manage and monitor the submission plan, ensuring its alignment with the priorities of the affiliate and the timelines established for each type of process. In addition, you will generate and propose regulatory strategies for the submission of CMC variations and coordinate the activities of the internal and external resources involved. Ready to get started?
Join the engine of Sanofi's mission, where deep immunoscience meets bold AI-driven research. In R&D, you will drive advances that could turn the impossible into the possible for millions of people.
About Sanofi:
We are a biopharmaceutical company driven by R&D and powered by AI, committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline allows us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we pursue the miracles of science to improve people's lives.
Key Responsibilities:
- Prepare and submit regulatory dossiers: prepare LCM variation dossiers (CMC, labeling, administrative) and renewals for all product categories (including biologics and vaccines), complying with local regulations and deadlines.
- Manage the submission plan: monitor the submission plan, aligned with the priorities of the affiliate and the timelines according to the type of process.
- Verify and complete documentation: review the completeness of the CPs and collect any missing items (CMC, GMP certificates, powers of attorney, clinical/non-clinical documentation, pharmacovigilance, final artwork, samples, etc.), including translations when required.
- Assess risks and ensure quality: carry out risk assessments and technical feasibility reviews before submission, anticipating possible authority requests to avoid delays.
- Respond to health authorities: prepare timely responses to HAQ and deficiency letters, following the strategies defined by CRM.
- Propose CMC regulatory strategies: generate and propose strategies for CMC variations, coordinating internal and external resources.
- Coordinate with key areas: act as the focal point with RSO, CMC Global, Operations, Labeling and IVT, and follow up to ensure document delivery.
- Maintain data and provide visibility: record dossiers and legal documents in the regulatory database, repor
About You
- Experience: Solid knowledge of regulatory affairs.
- Soft and technical skills: Results orientation and customer commitment. Ability to work cross-functionally and in matrix organizations. Teamwork, communication and influence skills. Adaptability to change and decision-making ability. Excellent strategic, relationship-building and influencing skills.
- Education: university degree
- Languages: English and Spanish; good reading comprehension, oral and written expression.
Why Choose Us
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to develop your talent and advance your career, whether through a promotion or a lateral move, locally or internationally.
- Enjoy a well-designed and thoughtful benefits package that recognizes your contribution and enhances your impact.
- Be part of a pioneering biopharmaceutical company that involves patients from the earliest stages of drug development and uses their perspectives to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, leveraging artificial intelligence, data and state-of-the-art digital platforms to push the boundaries of science.
- Help improve the lives of millions of people around the world by making drug development faster and more effective.
Pursue Progress. Discover the Extraordinary.
Join Sanofi and enter a new era of science - where your growth can be as transformative as the work we do. We invest in you to go further, think faster, and do what has never been done before.
You will help push boundaries, challenge conventions, and build smarter solutions that reach the communities we serve. Ready to pursue the miracles of science and improve people's lives? Let's pursue Progress and Discover the Extraordinary – together.
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!