Regulatory Cmc Manager

Regulatory Cmc Manager
Empresa:

Sanofi


Regulatory Cmc Manager

Detalles de la oferta

REGULATROY CMC MANAGER
(PLANTA OCOYOACAN Y CUAUTITLAN)

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
Support regulatory CMC activities for vaccines for Mexico by:

Provide regulatory CMC strategic support for the Vaccines Portfolio in Mexico
Provide support for the Vaccines manufactured at Ocoyoacac and Cuautitlan by:Authoring CMC dossiers
Liaising with Ocoyoacac and Cuautitlan IA and RA teams to ensure having all CMC data required
Authoring responses in case of CMC questions from HAs
Managing regulatory activities linked to change controls for Ocoyoacac and Cuautitlan sites

Support transversal projects and workgroups as per the direction of GRA CMC & D Vaccines in China.

Main Responsibilities:

Provide strategy management and coordination to the vaccines biologics portfolio in Mexico for products manufactured in Ocoyoacac and Cuautitlan sites.
Support Health Authority interactions for topics related to Ocoyoacac and Cuautitlan portfolio.

Support GRA CMC Product Focal Points and local GRA teams in preparation of HA meetings for ;
Represent GRA CMC at HA meetings in Ocoyoacac and Cuautitlan supporting discussion of CMC / manufacturing related topics

Manage regCMC related activities for the Ocoyoacac and Cuautitlan Vaccines portfolio:

Author CMC dossiers to support Ocoyoacac and Cuautitlan vaccines maintenance
Liaise with Ocoyoacac and Cuautitlan IA and RA teams to ensure having all CMC data required
Author responses in case of CMC questions from HAs for Ocoyoacac and Cuautitlan products

Support CMC Post Approval Commitments made in the frame of regulatory activities for Ocoyoacac and Cuautitlan products
Support CMC activities for the Vaccines Portfolio:Contribute to ad hoc CMC Task Forces when needed (e.g., in case of crisis situations)

Your competencies: To succeed in the role, we require candidates to have
Education:Chemistry Bachelor (Preferably)

Experience & knowledge:To succeed in the role, we require candidates to have:

Minimum 5 years experience in biopharmaceutical R&D manufacturing, Quality, etc. and experience in Health Authorities interactions in Mexico
Expertise and experience in one or more of the following areas: industrial quality, pharmaceutical /bio-research, bio-development including process development, analytical development and/or formulation development and/or GMP bio-manufacturing
Knowledge of Mexican pharma regulations.
Appropriate autonomy and working remotely, with Manager based in TBC, interactions with Regulatory CMC staff based in Europe and North America, as well as with regulatory staff based in Mexico

Language:Fluent in English and Spanish (mandatory). French (desirable)

Competencies:Strategic thinking, People management, Team leadership, Decision taking, Results oriented, Transversal cooperation.

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.


Fuente: Neuvoo1_Ppc


Área:

  • Otros / Otros

Requisitos

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