Director, Global Regulatory Affairs Strategy

Company: Sanofi
Location: Cambridge
Posted on: June 22, 2022

Job Description:

Job Highlights:

• The Global Regulatory Affairs Lead (GRTL) Immunology & Inflammation will be responsible for leading the Global Regulatory Team (GRT) in the development of innovative and creative global regulatory strategies for pipeline and lifecycle assets in Sanofi's growing and diversified Immunology & Inflammation portfolio.
• The person will serve as Sanofi's liaison to internal business partners including but not limited to the Global Project Team and represent regulatory at corporate governance meetings for assigned projects.
• In this role, the person will be accountable to lead the GRT and collaboratively develop and maintain the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects.
• The role works with and participates on multi-disciplinary matrixed project teams to effectively meet project deliverables while adhering to regulatory requirements for programs and products.
• The role participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations.
• The role may be assigned direct reports.
  Basic Qualifications:
  • BS/BA degree in a relevant scientific discipline required. Advanced degree is preferred (MS/MA/PharmD/Ph.D./ MD)
  • At least 6 years relevant experience in regulatory affairs (regionally and/or global) including 8 years relevant pharmaceutical/biotechnology industry experience.Preferred Qualifications:
    • Demonstrated strategic thinker with an ability to make complex decisions and willingness to defend difficult positions
    • Demonstrated leadership experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional health authority.
    • Demonstrated understanding of clinical development of drugs and/or innovative biologics products.
    • Effective communication skills, specifically excellent oral and written presentation skills
    • Excellent time-management and operational skills including planning, organizing and experience to effectively motivate and lead others.
    • Experience working in electronic document management systems, e.g. Veeva vault
    • Organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
    • Experience mentoring/coaching junior staff
    • Understanding of the global Immunology & Inflammation pharmaceutical marketplace, and drug development
    • Strong sensitivity for a multicultural/multinational environment.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.Fully vaccinated, 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, Cambridge , Director, Global Regulatory Affairs Strategy, Executive , Cambridge, Massachusetts