Position Title: LATAM Regulatory Affairs Coordinator

Location information: BR / São Paulo / Sanofi.

Job overview

Regional Lead for Marketed Portfolio Strategic Management of Vaccine BU providing Regional strategies and needs.

Responsibilities

• 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.

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Terms of employment

Availability for travelling;

Start date: Immediate;

40 hours/week

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