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.

Compiègne is the Consumer Health Care’s (CHC) largest and most important Global Development Center. It is equipped with a GMP Pilot Plant and located on an FDA certified Site. It is the key CHC Development Center for developing new NDA products based on conventional APIs including paracetamol, multi-vitamins... This strategic orientation requires the highest levels of excellence in Quality and Technical Regulatory work.

RESPONSIBILITIES

• Definition, application of the regulatory strategy and writing, according to the highest standards, of the technical CMC documentation for the assigned projects, including but not limited to Module 3 (CMC sections) of new Registration dossiers, IMPD documentation to support Clinical Trials and responses to Deficiency Letters from Health Authorities
• These documents summarize key technical information necessary to secure Health Authority approval to market new OTC Drug-status NPD products. A very high level of technical skill and knowledge is needed to conduct such work given the technical rigor needed to describe adequately the product (APIs & relevant chemistry), pharmaceutical processes and the multiple different regulatory requirements and challenges which need to be met (ICH Q3B, Q3D, M7 compliance, etc.)
• Further responsibilities include for Food-status products writing the necessary documents including the Technical File to summarize development work and key data
• The development of the products managed by the project teams may be done internally at Compiègne DC or on Sanofi CHC manufacturing sites or externally through CDMO partners
• The concerned products are part of the CHC portfolio (OTC medicinal products, and Food Supplements)

KEY RELATIONSHIPS

• Quality & Regulatory affairs global network (other development centers/manufacturing sites)
• Global Regulatory Affairs (GRA)
• Development center Colleagues and local Compiegne site staff

PROFILE

• 4 years’ experience minimum in regulatory departments of pharmaceutical industries as Regulatory Site Officer and/or in Development with good understanding of pharmaceutical regulation (previous experience with food status will be highly evaluated) and quality standards
• Strong pharmaceutical background (Pharmaceutical Sciences/Chemistry/Biology)
• Demonstrate outstanding knowledge of relevant Quality and Regulatory fields (cGMP, EMA, FDA, ICH, OTC and FOOD STATUS)
• Good knowledge of pharmaceutical technology and analytics
• Good autonomy and communication skills. Ability to interface effectively with multiple departments
• Ability to challenge or defend regulatory strategies
• Rigor and pragmatism
• Working proficiency in both English & French with very good writing skills in English
• Knowledge of Viva Vault and Phenix QTP tools will be appreciated
• Ability to work in a matrix organization and in complex and changing environment

Join us ...

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