Manager/Senior Manager, Regulatory Affairs

Company: Sanofi
Location: Framingham
Posted on: May 9, 2022

Job Description:

Job Title: Manager/Senior Manager, Global Regulatory Affairs-CMCDepartment: GRA CMC Biologics_______________________________________________________________________Job DescriptionThis position will lead the Chemistry Manufacturing and Controls (CMC) Regulatory strategy for Development and Licensed biological products.This position will direct and provide product strategy and direction to commercial and clinical teams.Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.Experience working in a matrix environment and excellent people skills are required.Additional duties include coordination with global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.Major Activities/Key Responsibilities

• Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval:
  • New applications for biological products
  • Post-Marketing Commitments (PMCs), Follow-up Measures (FUM) and other regulatory commitments
  • License Maintenance:
    • Post Authorization Changes
    • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
    • Responses to Questions
    • Lead contact and interface with Health Authorities and affiliates on CMC topics
    • Interface with regulatory colleagues in matrix environment and in project teams, working together to achieve submission and approval goals.
    • Competent use of regulatory database systems for timely recordkeeping and reporting.Ideal Background (preferred education and experience level)QualificationsBasic Qualifications:
      • M.S. degree -in a scientific discipline -with 6 years regulatory experience, or B.S. with 8 years regulatory experience
      • 8+ years' experience in regulated pharmaceutical/biologics job environments; 4-6 years biologics experience required
      • Strong background in biologics drug development, manufacture, or testingPreferred Skills:
        • Familiarity with combination products
        • Proficient in MS Word, Excel, PowerPoint
        • Excellent organizational and communication (English written and verbal) skills.
        • Demonstrated ability to work successfully on global project teams.
        • Previous experience working in a fast-paced environment on multiple product lines
        • PhD is considered a plus
        • Manufacturing, QA/QC experience desirableSanofi 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 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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.#GD-SA#LI-SAAt 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.

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