Regulatory Site Officer

Description de l'offre

Le site de Sanofi Vitry recherche son Responsable Réglementaire H/F

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

KEY ACCOUNTABILITIES

Regulatory Compliance

·  Ensures that the CMC dossier is in line with manufacturing and control procedures on site and with dossiers approved by Health Authorities

Change Control

·  Provides regulatory expertise to site projects
·  Assesses and manages Change Control activities with regulatory impact on his/her site(s)

CMC Documentation management

·  Manages, coordinates and ensure the writing of CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission including answers to questions from Health Authorities
·  Supports product licenses maintenance and site registrations: supports Marketing Authorizations worldwide (renewals, site registrations and transfers…) by ensuring the writing of the corresponding CMC documents/dossiers and collecting GMP related documents from the site.

Transversal activities

·  Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs or with external partners for his/her site
·  Implements the appropriate company tools to manage all his/her activities
·  Contributes to site inspections and audits
·  Supports all regulatory topics and projects for Biotech on the site by providing regulatory expertise and evaluations
·  Reviews and signs-off site documents such as analytical SOPs, manufacturing process instructions or different type of technical reports
·  Planning, tracking and reporting of regulatory activities/ approvals to the Site Quality Head as well as to the different project managers

Management

Manages and develops the team under his/her responsibility as applicable

REQUIREMENTS

·  Master's degree or equivalent in Pharmaceutical/ Biotech/ Life sciences
·  Over 10 years' experience and/or a degree in the field of Drug API industry, biotech experience preferred
·  Fluency in English (both oral and written communication)
·  Knowledge/ Experience in Chemistry Manufacturing and Control (CMC)
·  Knowledge/ Experience in CMC writing; writing of technical documents and reports
·  Knowledge/ Experience in Regulatory registration and maintenance, GMP and health-related regulations
·  Project management skills
·  Management skills

Sanofi is committed to welcoming and integrating people with disabilities

Sanofi s'engage en faveur de l'accueil et de l'intégration des personnes en situation de handicap.

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.