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Manager Global Regulatory Affairs CMC Biologics

Company: Sanofi
Location: Cambridge
Posted on: November 24, 2022

Job Description:

Position Title: Manager Global Regulatory Affairs CMC BiologicsJob Overview:

  • As the GRA CMC Product Focal Point (PFP), this position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.
  • Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
  • Provide support for other CMC projects as needed.
  • Experience working in a matrix environment and excellent people skills are required. Responsibilities:
    • New applications for biologics
      • Plan/Prep/Submit/Review support for product dossiers
      • CTA / IND preparation and maintenance
        • License Maintenance
          • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
          • Site renewals (ex. Japan Accreditation)
            • Post Approval Supplements
              • Regulatory strategy development
              • Preparing / Authoring / Review of Submissions - US, EU and Rest of World (ROW)
              • Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
              • Notify Reg Ops for publishing and dispatch to BoH
              • BoH Response to Queries - US, EU and ROW
              • Interaction / liaise with EMA and EU member state BoH on CMC topics
                • Change Controls
                  • Change control assessments
                  • Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
                    • Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.Requirements & Qualifications:
                      • University degree in scientific discipline with at least 3 years regulatory experience or relevant industry experience.
                      • Knowledge of FDA regulations is essential.
                      • Experience with biological products Preferred Skills:
                        • Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
                        • Excellent organizational and communication (written and verbal) skills.
                        • Demonstrated ability to work successfully on project teams.
                        • RAC certification preferred.
                        • Previous experience working in a fast paced environment on multiple product lines
                        • Manufacturing, QA/QC experience At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 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. As 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. 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.

Keywords: Sanofi, Cambridge , Manager Global Regulatory Affairs CMC Biologics, Executive , Cambridge, Massachusetts

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