Job title:_ Senior Regulatory Affairs Associate_
- _ Location: CDMX_
- _ 70% Remote working_
- _ Job type: Permanent_
- About the job
- Our Team:
- Elaboration of dossier for LCM variations (CMC, Labeling, Admin) and renewals according to local requirements (all products categories, including Biological and vaccines). Elaboration of HAQ responses according to strategies defined by CRM._
- Elaborate and follow up dispatch plan in alignment with affiliate’s priorities and established deadlines according to process type._
- Generate and propose to the regulatory affiliate regulatory submission strategies for the CMC variations received._
- Main responsibilities:
- Responsible for CP verification, dossier elaboration and dispatch of products from relevant BUs to the countries in charge, ensuring compliance with local regulations and accomplishing timing needs.
- Responsible for the dispatch plan of respective dossiers.
- Focal point for communication with customers / interfaces
- Preparation of Risk Assessments of the dossiers before dispatch, including technical viability, when applicable.
- Responsible for review of CP completeness and gathering missing documents/information from responsible teams for the completion of dossier to be dispatched, according to the legislation.
- Translation of the dossiers when required by legislation.
- Ensure the quality of dossiers, identifying possible requirements that may be presented, to avoid processing time increase.
- Responsible to include in database the dossier and legal documents dispatched to the countries.
- Participation in internal meetings and external meetings for training.
- Ensure timely dispatch of dossier to the countries in charge.
- Make follow-up to RSO of manufacturing site/CMC team, assuring the dispatch of necessary documents for dossier.




- Answer opportunely the deficiency letters issued by Health Authorities of the countries in charge.
- Give accurate and timely information to maintain regulatory data base updated.
- Give visibility to the upper management of main challenges faced locally and provide suggestions of improvement whenever applicable.
- About you
- Experience: _Relevant experience as a Regulatory Affairs Senior Associate or similar role in the pharmaceutical industry. Experience working with different regulations in a LATAM scope._
- Soft skills:
- _ Strong stakeholder management and teamwork skills._
- _ Excellent negotiation, communication and influencing skills._
- _ Demonstrated autonomy and ownership._
- Technical skills: _Strong knowledge of regulatory affairs in LATAM region. Knowledge on _biological and vaccines products regulation_._
- Education: _Bachelor’s Degree_
- Languages: _Intermediate English_
- 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
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and check out our Diversity Equity and Inclusion actions at
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LI-LATAM
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

📌 Senior Regulatory Affairs Associate (Ciudad de México)
🏢 Sanofi
📍 Ciudad de México