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(Senior) Associate Regulatory CMC - Innovative Biologics

Company: Sanofi
Location: Mendham
Posted on: June 20, 2022

Job Description:

About the opportunityJoin Sanofi as a (Senior) Associate Regulatory CMC where you will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for development and marketed innovative biologics (mAbs, proteins, Nanobodies, Synthorins, cell and gene therapies). In this critical role, you will have the opportunity to work on diverse cutting-edge projects, provide input into the product strategy, global development/commercial teams and local sites as well as assuring regulatory submissions are on time and high quality.About SanofiSanofi is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.About growing with usIn this role you will

  • Coordinate and prepare document packages for regulatory submissions, ensuring compliance with required regulations and interpretations.
  • Provide project team representation and act as liaison to obtain information from other departments regarding regulatory submissions or documentation.
  • Review technical documentation and recommend changes for regulatory compliance ensuring conformances with existing regulatory approvals.
  • Research and analyze regulatory information.
  • Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes.
  • Support all aspects of assigned ad-hoc or planned regulatory projects with internal teams or affiliates.Main activities / key responsibilities
    • New applications for drugs/biologics
      • Plan/Prep/Submit/Review support for product dossiers
      • CTA / IND preparation and maintenance
        • License Maintenance
          • Recurrent filings: annual reports (e.g. 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
              • Response to Queries - US, EU and ROW
              • Interaction / liaise with EMA and EU member state 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.About youQualifications/Education & work experience
                      • University degree (PhD, MSc, BSc) or similar qualification
                      • Background in regulatory affairs for human medicinal products, vaccines or biologics drug development and manufacture, testing
                      • 4+ years' experience in pharma environments
                      • Proven expertise / experience with assessing biologics CMC source documentation, writing/reviewing CMC dossier documents, managing regulatory information systems or procedures at health authorities
                      • Previously worked with internal and external collaboration partners in a matrixed organization is a plus
                      • Regulatory certifications preferredCompetencies
                        • Excellent organizational and communication (written and verbal) skills.
                        • Proficient in using digital tools (MS Word, Excel, PowerPoint, regulatory databases and document management systems)
                        • Patient- and quality-focused mindset and able to drive a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards.Inspire your Journey, what Sanofi can offer you:
                          • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
                          • An individual and well-structured introduction and training when you onboard
                          • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
                          • As a globally successful and constantly growing company, Sanofi provides international career paths as wellThis is our Sanofi, Discover yours.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.#GD-SG
                            #LI-GZAt 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, Newark , (Senior) Associate Regulatory CMC - Innovative Biologics, Other , Mendham, New Jersey

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