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Senior Associate Global Regulatory Affairs CMC

Bridgewater, NJ;Cambridge, MA;Westborough, MA

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

Job Description

This position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical biological products. This position may provide input into the product strategy for commercial and clinical teams.  Incumbent will be responsible for supporting the defined regulatory strategy which is aligned with Health Authority requirements from a global perspective and assuring regulatory submissions are on time and high quality.

Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites, communication to senior management and our partners (including Quality and Supply Chain). 

Creates collaborative working relationships with Global Regulatory Affairs (GRA CMC &Devices, Regions and Country Regulatory Groups), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management (R&D Development, Innovation, Pharma Operations teams), Regulatory Health Authorities, Others

Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.  

Major Activities/Key Responsibilities

  • New applications for biologics:
    • Plan/Prep/Submit/Review support for product dossiers
    • CTA / IND preparation and maintenance
  • License Maintenance
    • Recurrent filings: (US, Canadian NDC and YBPR, license and renewals)
    • Site renewals (ex. Japan Accreditation)
  • Post Approval Supplements
    • Regulatory strategy development
    • Preparing / authoring / review of submissions per Sanofi way of working – US, EU and Rest of World (ROW)
    • Technical Review of site supporting specific documents (CoA, declarations, etc)
    • Notify GRA Ops for publishing and dispatch as required
    • Responses to Health Authority questions – US, EU and ROW
    • Interaction / liaise with FDA, EMA on CMC topics

  • Global Regulatory CMC Strategies and risk assessments for development projects and/or marketed products in collaboration with other parts of GRA
    • Assures positive and collaborative relationships with CMC teams to achieve implementation of appropriate regulatory strategies
  • 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 as required.

Qualifications

Basic Qualifications:

  • University  degree in scientific discipline with 2- 5 years regulatory experience or equivalent experience
  • Knowledge FDA regulations is required
  • Experience with biological and/or small molecule products

Preferred Skills:

  • Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems
  • Excellent organizational, communication (written and verbal) and negotiation skills.
  • Analytical, accurate with an eye for detail
  • Demonstrated ability to work successfully on project teams.
  • Analyses possible solution using standard procedures
  • Previous experience working in a fast paced environment on multiple product lines
  • RAC certification preferred.

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.

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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.

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