Associated Director Regulatory CMC - Innovative Biologics

Company: Sanofi
Location: Bridgewater
Posted on: June 23, 2022

Job Description:

Associated Director Regulatory CMC - Innovative BiologicsAbout the opportunityJoin Sanofi as an Associated Director - Innovative Biologics where you will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for development and marketed innovative biologics products (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. As an Associated Director you will support the leadership team managing the team and the portfolio.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

• Act as the GRA CMC Biologics representative in project / product teams
  • represent GRA CMC Biologics in Global CMC and Global Regulatory Team(s) and meetings, partners with the leaders of these teams to facilitate successful product development
  • provide accurate regulatory assessments and expertise input to team recommendations
  • facilitate together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, meetings, etc.)
  • Communicate project plans, status and updates to management
    • Develop and execute global regulatory CMC strategy for assigned product
      • Gather and assemble needed CMC source information, regulatory requirements relevant for the product, regulatory intelligence in the field
      • Develop, align and formulate the global regulatory CMC strategy and write strategy documentation
      • Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations
      • Support CMC regulatory risk assessments, and drive contingency planning and mitigation of identified regulatory risks
        • Manage global regulatory submissions and dispatches of CMC packages for new applications / maintenance-, amendment-, supplement-, response submissions etc.
          • Plan submissions and CMC dossier/package strategies per the product's global CMC regulatory strategy for CTA/INDs, BLA/MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc.
          • Determine and gain alignment on the required content for CMC dossiers and timelines
          • Coordinate and support dossier preparation, review and publishing process in line with project timelines
          • Manage regulatory databases for planning and tracking of regulatory submissions
            • Manage CMC related Health Authority liaison and communication
              • Interact and liaise with FDA, EMA on product and CMC topics, coordinates health authority interactions on CMC topics with international Health Authorities and together with local/regional teams
              • Under the supervision of senior GRA CMC staff: Lead the Regulatory CMC content of meetings with FDA, EMA, supports Health Authority meetings as SME in international countries
              • Communicate outcomes of health authority procedures or feedback to teams and management
              • Track HA communication and questions/responses in regulatory databases
                • Support compliance requirements and activities
                  • Provide CMC regulatory input to change management processes
                  • Ensure regulatory events are tracked in central databases
                  • Prepare reports on regulatory plans and status for management and development/industrial committees
                  • Support dossier compliance activities, health authority inspections and internal/external audits as needed
                    • Support the leadership team
                      • Mange a cluster of products from the team's portfolio
                      • Mentor or supervise regulatory associates and (junior) managers
                      • Represent GRA CMC in governance meetings and committees with internal and external partners
                      • Support Regulatory intelligence activities, reviewing and commenting of HA guidelines, process improvement, strategic initiativesAbout youQualifications/Education & work experience
                        • University degree (PhD or MSc) in a life science discipline
                        • Strong background in biologics drug development and manufacture, testing
                        • 8+ years' experience in regulated pharma environments (research, development, manufacture or analytics) out of which at least 4 years in a regulatory CMC or quality department or as technical/scientific reviewer at competent authorities
                        • Proven expertise / experience with assessing biologics CMC source documentation, writing/reviewing CMC dossier documents, managing regulatory procedures and health authority interactions
                        • Knowledge of global regulations on Biologics drugs
                        • Previously worked with external collaboration partners and/or CROs/CMOs is a plus
                        • Regulatory certifications preferredCompetencies
                          • Excellent organizational and communication (written and verbal) skills.
                          • Previous experience in an international, matrixed, fast-paced environment is a plus
                          • 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, Trenton , Associated Director Regulatory CMC - Innovative Biologics, Executive , Bridgewater, New Jersey