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Director, GRTL Regulatory Affairs, Immunology

Bridgewater, New Jersey, Toronto, Canada

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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Quote

"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

The Director, Regulatory Affairs (Global Regulatory Team Lead) is part of the Global Regulatory

Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU) and will report to the Regulatory Disease Area Head on a high profile, fast-paced, large multi-indication program within Immunology Therapeutic Area (TA). The role will be responsible for developing and executing on long and short-term global regulatory strategies including late-stage development/submission activities for selected indications under their accountability. The role will also be responsible for development of the US regulatory strategy for the selected indications.

Job Highlights

  • The Global Regulatory Affairs Team Lead (GRTL) within the Immunology TA will be responsible for leading the Global Regulatory Team (GRT) in the development of innovative and creative global regulatory strategies for assigned pipeline and lifecycle assets in Sanofi’s growing and diversified Immunology portfolio.  Specifically to lead regulatory strategies including late-stage development/submission activities for selected indications under their accountability for a high profile, fast-paced, large multi-indication program.

  • 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 will also be responsible for development of the US regulatory strategy for the 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.

  • The position is based in the North America preferably in the Cambridge MA or Bridgewater NJ Area, or Toronto, Canada. Location could be flexible.

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.

Languages: English

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 pharmaceutical marketplace and Immunology 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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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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