Associate Director, Global Regulatory Affairs, Early Immunology and Inflammation
Posted on: May 14, 2022
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
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
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
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
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.
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.
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
Ability to work in electronic document management systems, e.g.,
Experience mentoring/coaching junior staff is a plus.
Strong sensitivity for a multicultural/multinational
The position is based in Ghent, Diegem (BE), Amsterdam (NL),
Cambridge MA or Bridgewater NJ (US). - Location could be
Pursue Progress. Discover Extraordinary
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
Keywords: Sanofi, Trenton , Associate Director, Global Regulatory Affairs, Early Immunology and Inflammation, Healthcare , Bridgewater, New Jersey
Didn't find what you're looking for? Search again!