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North American Lead Rare Blood Disorders

Bridgewater, NJ;Cambridge, 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

The role is primarily responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for assigned therapeutic area which adhere to US regulatory and company guidelines.  In addition, the role represents Sanofi to the US FDA for assigned projects and leads the strategic development of documentation submitted to the US FDA and leads FDA meetings. Further, the role represents the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents and for US regulatory issues at internal governance meetings. In addition, the role prospectively works with the NA labeling strategist and the Global Regulatory Team to develop 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 and products. 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 may supervise, and/or coach mentor, junior staff supporting regulatory team

The position may be based at either Bridgewater, NJ or Cambridge, MA sites.

Specific responsibilities include:

  • Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare blood disorders indications which adhere to US regulatory and company guidelines.
  • Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
  • Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
  • Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
  • Represent Sanofi at US FDA for assigned projects.
  • Work with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information.
  • Work with and participate on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products.
  • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
  • Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
  • Supervise, and/or coach mentor, junior staff supporting regulatory team.
  • Ensure compliance with all regulatory and internal Sanofi policies

Minimum Requirements:

  • At least 5-8 years’ regulatory experience in drug development.
  • 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 rare blood disorders drug development.
  • Demonstrated experience successfully operating in a global environment.
  • B.A./B.S. or higher degree (s) in the sciences, or health related field minimum (Advanced scientific degree preferred)

Knowledge, Skills and Other Experience

  • Strategic thinker
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
  • Direct interaction/negotiation experience with US FDA.
  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  • Excellent operational skills including planning, organizing and ability to motivate and lead others.
  • Ability to work well within cross-functional globally oriented teams
  • Demonstrates excellent oral communication and writing skills
  • 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.
  • 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
  • Ability build networks to obtain cooperation without relying on authority
  • Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values

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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