About the job

External Manufacturing and Supply Large Molecule Specialty Care (EM&S LM SC) is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs), Distribution Centers and business partners involved in the manufacture, testing, storage and transport of Sanofi products. EM&S LM SC staff interact with functional units within other Sanofi sites, and other organizations within the External Manufacturing and Supply and Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediates (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

• EM&S LM SC has responsibility for CMO and CLO and distribution activities related to products treating Rare Diseases and Rare Blood Disorders, Multiple Sclerosis (MS), and Oncology.

• EM&S LM SC has offices based in Northborough and Cambridge, MA US; Frankfurt Germany; Ghent and Geel, Belgium and Amsterdam, the Netherlands

Main responsibilities:

This function can also support to other EM&S entities than EM&S LM SC.

• Acts as a local regulatory interface between the external and internal manufacturing sites, quality units, MSAT, Global Regulatory Affairs and Sanofi affiliates

• Collaborates closely with EM&S LM SC personnel in order to ensure compliant manufacturing and release operations

• Manages and reviews CMC (Chemistry, Manufacturing and Controls) dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility

• Reviews and approves cGMP or regulatory reports / change controls / protocols/ submissions and associated action plans in order to ensure regulatory and cGMP compliance

• Analyses complex regulatory issues and processes, supports to build regulatory strategic plans and applies own professional knowledge to identify key areas of risk to compliance with registered details

• Acts as a source of regulatory expertise for others and gives advice on own area to other functions and employees

• Supports and ensures GMP and regulatory compliance and inspection readiness for products under ownership of EM&S LM SC

• Supports dossier Compliance program in compliance to Sanofi Global Procedures.

• Support for Deviation and CAPA

Additional Responsibilities

• Support the Qualified Person in any GMP and regulatory aspects related to batch release of product, as applicable

• May support internal regulatory assessment of information to support internal or external audits and supplier qualification as required

• Support CMO compliance via GxP and regulatory documentation review and on-site visits/Person in Plant/audits if applicable.

• Frequent inter-departmental, inter-organizational and external interactions

• Support the development and management of quality agreements between Sanofi and the contractor

• Support program for maintaining performance metrics

About you

Education

• Bachelor’s degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment. OR

• Master’s degree with scientific background and 3 years of experience in a GxP or regulatory affairs environment

Experience

• A working knowledge of conventional and biotechnological and small molecule manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficial.

• Experience within EM&S environment and/or as regulatory compliance responsible is an asset.

• Knowledge and experience with regulatory database system (Veeva RIM) is an asset.

Soft and technical skills:

• Good understanding of quality and regulatory systems and management tools.

• Knowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.

• Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

• Problem solving and technical writing skills.

• Ability to multitask effectively

• Willingness to travel

Languages: Good written and verbal communication in English