REGULATORY AFFAIRS COORDINATOR
Sanofi is one of the mayor players in the pharmaceutical industry with a proven footprint in Vaccines, Consumer Health Care, and Primary & Specialty Care.
Do you wish to change patient lives? Are you prepared to use your excellent business and people skills? Innovation is part of your way of working? Are you passionate about transformation and leading change?
In this Role
You will be responsible for the coordination of assigned projects in Latin America, supporting the definition of regional regulatory strategy aligned with commercial and medical objectives, and ensure the execution.
Your competencies: To succeed in the role, we require candidates to have:
Education: Bachelor of Pharmaceutical Chemistry
Experience & knowledge: To succeed in the role, we require candidates to have:
· 4 years of experience in the pharmaceutical industry, in Regulatory Affairs (global, regional, or local).
· Languages: Advanced English is required.
- Support the development and implementation of a Regulatory Strategy for assigned projects, including its risk mitigation plans, as applicable;
- Support activities related to Business Development assessments, as applicable;
- Prepare, validate & follow-up the registration plans with regulatory affiliates & other involved functions, for assigned projects (including annual RAP - Regulatory Affairs Plan - and other ComOps interactions, for Sa-Pasteur);
- Coordinate with other functions the preparation, dispatch & follow-up until the approval (including MoH questions) of the assigned regulatory applications in a timely manner, including new registrations or register renewals
- Support the preparation of the dossiers (briefing package, slide kit) for pre-submission meetings, as requested;
- Ensure regulatory database is updated in a timely manner;
- Coordinate the development of the response strategy and the preparation of MoH’s response documents with concerned functions for new applications and line extensions for assigned projects;
- Coordinate the process for Product Alerts and Product Discontinuations in the region and support required actions to be taken within a timely manner;
-Provide support in assigned Global Regulatory Teams, ensuring the best regional contribution for the GRPS and following the Blueprint process;
- Collect & track with the affiliates, via regular meetings & through monthly reports, the regulatory activities for the assigned projects;
- Ensure the correct understanding of the requirements for a regulatory application at global and regional levels in order to ensure compliance with local legislations and mitigate risks;
- Support product tenders, if applicable;
- Support labelling activities related with harmonized packaging materials for the region.
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.