The Regulatory Site Officer (RSO) will be both technical and product expert in support of multiple product registrations supporting ESQA staff to maintain regulatory compliance. This role will be expected to interface with RSO’s at multiple Sanofi sites to support release activities as well as connecting with external manufacturers and partners on regulatory matters.
· Acts as a focal regulatory interface between the external and internal manufacturing sites, quality units, MSAT, Global Regulatory Affairs and Sanofi affiliates
· Collaborates closely with External Supply Quality Assurance personnel in order to ensure compliant manufacturing and release operations
· Reviews and approves cGMP or regulatory reports / change controls / protocols/ submissions and associated action plans in order to ensure regulatory and cGMP compliance
· Manages CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility
· Analyses complex regulatory issues and processes and applies own professional knowledge to identify key areas of risk to compliance with registered details
· Acts as a source of technical expertise for others and gives advice on own area to other functions and employees
· Frequent inter-departmental, inter-organizational and external interactions
· Support the development and management of quality agreements between Sanofi and the contractor
· May lead internal regulatory assessment of information to support internal or external audits and supplier qualification as required
· May have involvement in additional ESQA projects to support compliant quality of product as required
· Support program for maintaining performance metrics
· Bachelor’s degree with scientific background or equivalent (e.g. Regulatory or Engineering) and
· 5-7 years of experience in a GxP or regulatory affairs environment.
· Master’s degree with scientific background and
· 3-5 years of experience in a GxP or regulatory affairs environment, to include 2 years in a regulatory affairs role.
· In-depth understanding of quality and regulatory systems and management tools.
· Broad knowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.
· A working knowledge of conventional and biotechnological manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficial.
· Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
· Strong written and verbal communication and project management skills and the ability to multi-task effectively.
· Problem solving and technical writing skills.
Special working conditions:
· Ability to travel up to 15% - primarily domestic - is required.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.