Position Title: LATAM Regulatory Affairs Coordinator
Location information: BR / São Paulo / Sanofi.
Regional Lead for Marketed Portfolio Strategic Management of Vaccine BU providing Regional strategies and needs.
- Coordinate activities required for dossier evaluation and dispatch of products from relevant Vaccines BU, ensuring compliance with local regulations and accomplishing timing needs.
- Coordination of all activities for the assigned projects
- Request all documents according the legislation (ie, (CMC documents and Administrative docs: GMP, PoA, trademarks certificates, etc, Clinical/ non clinical, PV docs, Artworks, Samples) to Global /RA Affiliates/ RSO for Territory extension/Registration of Products.
- Coordinate the submission of the dossiers in accordance with the legislation of the corresponding countries.
- Coordinate the communication with Development, RSO and Global CMC, Operation; GRTL
- Develop and maintain update the knowledge of the legislation of the countries.
- Ensure the submission of dossiers, identifying possible requirements that may be done by Heath Authority, in order to avoid processing time increase.
- Assist the Maintenance and Life Cycle Management Committees to be aligned with Development/Industrial/Quality and Commercial area in decision regarding the products in the market.
- Participate in the Global Regulatory Team meetings for the products assigned;
- Keep track of submissions to the region.
- Coordinate the answer of deficiency letters originated by Health Authorities (review information, coordinate times of response).
- Make follow-up and establish prioritization to the Clinical /RSO/Global CMC team in preparation of Dossier.
- Ensure timely shipment of renewals and post approval changes (formula changes, shelf life, specifications update etc).
- Coordinate the translation of the dossiers when required according the local legislation
- Participation in internal meetings and external meetings for training;
- Optimization of ways of working, ensuring continuous improvement of regulatory tools.
- Act as focal point for the region giving Regional strategies and needs.
Requirements & Qualifications
- Education level: Pharmaceutical Chemical Professional
- Knowledge in Biological products (vaccine)
- Preferably have worked in similar positions in the pharmaceutical industry.
- Strive for results, Commitment to Customer, Cooperate Transversally.
- Demonstrated and recognized capacity to work in a matrix organization;
- Strong teamwork ability: interpersonal & communication skills;
- Demonstrated capacity to Act for Change;
- Ability to Make Decisions;
- Excellent strategic, networking and influencing skills;
- Strong Knowledge of regulatory affairs;
- Language requirements: Good level of reading, spoken and written English and Spanish.
Terms of employment
Availability for travelling;
Start date: Immediate;
What makes this position unique?
The opportunity on working in a multi-cultural and multi-disciplinary team, and the contact with several areas/departments/ countries in the company.
Benefits of working in this role
Development of technical and regulatory knowledge.
Para se candidatar a esta vaga cadastre seu currículo em https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/So-Paulo/Specific-Regulatory-Affairs-Position_R2519137