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Regulatory Site Officer

Company: Sanofi
Location: Cambridge
Posted on: June 22, 2022

Job Description:

Specialty Care External Supply (SCES) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. SCES staff interact with functional units within Biologics Corporate Quality (BCQ), Sanofi sites, and other organizations within the Biologics network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality of product supplyCORE RESPONSIBILITIES

  • 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 Specialty Care External Supply personnel in order to ensure compliant manufacturing and release operations
  • Manages CMC 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 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 employeesADDITIONAL RESPONSIBILITIES
    • Frequent inter-departmental, inter-organizational and external interaction
    • Support the development and management of quality agreements between Sanofi and the contractor
    • May lead an internal regulatory assessment of information to support internal or external audits and supplier qualification as required
    • Support program for maintaining performance metricsBASIC QUALIFICATIONS
      • Bachelors degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment; or
      • Masters degree with a scientific background and 3 years of experience in a GxP or regulatory affairs environment, including 2 years in a regulatory affairs rolePREFERRED QUALIFICATIONS
        • 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 multitask effectively.
        • Problem solving and technical writing skillsAs a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.According to the CDC, an individual is considered to be fully vaccinated fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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.#GD-SG#LI-GZPDNAt 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.by Jobble

Keywords: Sanofi, Cambridge , Regulatory Site Officer, Other , Cambridge, Massachusetts

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