Director, Regulatory Affairs, North America

Company: Sanofi
Location: Cambridge
Posted on: July 30, 2022

Job Description:

JOB DESCRIPTION:The US Regulatory Affairs Lead is responsible for the proactive development of innovative and robust US regulatory strategies for pipeline and lifecycle assets in Sanofi's Rare Disease & Rare Blood Disorders portfolio.He/she will be accountable for the efficient and effective execution of US regulatory strategies while adhering to US regulatory and company guidelines. The US RA Lead will serve as Sanofi's liaison to the US FDA for assignedrare disease projects in clinical development, which may include small molecules, biologics and gene therapy programs. In this role, he/she will lead the strategic development of documentation submitted to the US FDAand lead FDA meetings and negotiations. Further, the role represents the US GRA perspective as a member of the project specific cross functional global regulatory team (GRT). In this capacity, he/she will be accountable todevelop and maintain the US regulatory strategy documents and advise on US regulatory issues at internal governance meetings. In addition, the role prospectively works with the labeling strategist and the GRT todevelop US prescribing information. The role works with and participates on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs andproducts. The role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations. Lastly, the role will coach andmentor junior staff supporting the regulatory team.COMPETENCIES FOR SUCCESS:Strategic & Technical Regulatory Affairs Expertise:

• Strategic thinker
• Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
• Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
• Demonstrated experience with preparation of initial BLA, NDA, or MAA, INDs, Health Authority meeting briefing documents
• Understanding of the development of drugs and/or innovative biologics products.Experience in orphan drugs a plus Communication & Influencing:
  • Develops collaborative relationships to facilitate the accomplishment of work goals
  • Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
  • Excellent oral and written presentation skills - Direct interaction/negotiation experience with US FDA
  • Ability to work well within cross-functional globally oriented teams
  • Demonstrates excellent oral communication and writing skillsOther Personal Characteristics:
    • Excellent operational skills including planning, organizing and ability to motivate and lead others
    • Ability to work in electronic document management system
    • Thorough understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology
    • Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
    • Ability build transversal networks to obtain cooperation without relying on authority
    • High standards of integrity - Strong interpersonal skills - Dedicated and persuasive "can-do" attitude
    • Independently motivated, detail oriented and good problem solving ability
    • Self-motivated; entrepreneurial spirit; excellent time management skills
    • Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders
    • "Think out of the box" mindsetEXPERIENCE:
      • At least 8 years experience in Regulatory Affairs strategy
      • Solid working knowledge of drug development process and US regulatory requirements
      • Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs
      • Experience with drug development in the field of rare disease or gene therapy is preferred
      • Demonstrated experience successfully operating in a global environment
      • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field, minimum 8 years regulatory strategy experience
      • Regulatory Certification (RAC) (optional)
      • Fluent English required; additional languages desirableAt 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-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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