Associate Director, Global Regulatory Affairs, Early Immunology and Inflammation

Company: Sanofi
Location: Bridgewater
Posted on: May 14, 2022

Job Description:

Sanofi Genzyme 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 purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect, and integrity.

About the Opportunity

The Associate 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 early Immunology & Inflammation (I&I) Manager on a high profile, fast-paced, large multi-indication program within I&I Therapeutic Area. The role will be responsible for developing and executing on short and long-term global regulatory strategies including early-stage development/submission activities for selected indications under their accountability.

About growing with us

In this role you will---
be responsible lead the Global Regulatory Team (GRT) in the development of creative and thorough global regulatory strategies for pipeline and lifecycle assets in Sanofi's growing and diversified I&I TA portfolio.
serve as Sanofi's liaison to internal business partners including but not limited to the Global Project Team and represents regulatory at corporate governance meetings for assigned projects.
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.
work with and participates on multi-disciplinary matrixed project teams to effectively meet project deliverables while adhering to regulatory requirements for programs and products.
participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations.

About you

Qualifications/ Education & work experience
BS/BA degree in a relevant scientific discipline required. - Advanced degree is preferred (MS/MA/PharmD/Ph.D./ MD).
At least 4 years relevant experience in regional or global regulatory affairs function including 6 years relevant pharmaceutical/biotechnology industry experience.

Preferred Qualifications
Experience with leading the preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, or Health Authority meeting briefing documents and negotiating with a national/regional health authority.
Demonstrated understanding of clinical development of drugs and/or novel biologics products.
Effective communication skills, specifically excellent oral and written presentation skills.
Excellent organization and operational skills including planning, organizing and demonstrated ability in motivating and leading teams.
Ability to work in electronic document management systems, e.g., Veeva vault.
Experience mentoring/coaching junior staff is a plus.
Strong sensitivity for a multicultural/multinational environment.

The position is based in Ghent, Diegem (BE), Amsterdam (NL), Cambridge MA or Bridgewater NJ (US). - Location could be flexible.
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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.

Keywords: Sanofi, Trenton , Associate Director, Global Regulatory Affairs, Early Immunology and Inflammation, Healthcare , Bridgewater, New Jersey