Associate Director, Regulatory Affairs
Posted on: November 23, 2021
This is an exciting time to join the team focused on Oncology.
-Hear from our Clinical Development leaders, Peter Adamson and
Dietmar Berger , on our Oncology pipeline. You can also learn more
from our 2021 investor presentation focused on Oncology.
The Global Regulatory Affairs Lead (GRTL) for Oncology is
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 oncology portfolio. - 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 Governance
meetings for assigned projects. - In this role, the person will be
accountable to develop and maintain the Global Regulatory Strategy
and Plan for assigned projects in collaboration with the GRT. - In
addition, the role prospectively works with members of the GRT to
ensure a cohesive global regulatory and labeling strategy. - 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 position
is based in the US.
Ability to assess complex regulatory challenges and suggest
Partner across Regions at a project level to ensure transparency
and alignment of global and regional regulatory plan.
To effectively work in a highly matrixed organization to
proactively develop and document creative, thorough global
regulatory strategies for pipeline and lifecycle assets in clinical
development addressing regulatory risks and mitigations, global
submission strategies, and reimbursement strategies through
collaborative partnership and leadership of Global Regulatory
Function as a strategic partner for cross-functional Global Product
Teams (GPTs) to develop differentiated products with optimized
labeling. In this capacity, the role will serve as the single point
of contact for the business and R&D on regulatory issues for
Ensure timely communications of relevant topics to the business and
up through GRA Senior Management.
Ensure compliance with all internal and external requirements and
procedures and may suggest improvement to operating
policies/processes, as appropriate.
Bachelor's degree and at least 6.5 years in Regulatory Affairs or
relevant industry experience.
Master 's, PharmD, PhD degree and at least 4.5 years in Regulatory
Affairs or relevant industry experience.
Education area of study in a scientific discipline/MS or Doctoral
degree/Pharm D a plus.
Knowledge, Skills and Other Experience :
Strategic thinker with the ability to generate creative solutions
to complex problems, identifying different and novel ways to find
Demonstrated experience with preparation of initial BLA, NDA, or
MAA, INDs, 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.
Demonstrated ability to develop collaborative relationships to
facilitate the accomplishment of work goals.
Demonstrated ability to use appropriate interpersonal styles and
techniques to develop internal networks and lead negotiations with
internal and external stakeholders.
Effective communication skills, specifically excellent oral and
written presentation skills.
Ability to work well within cross-functional globally oriented
Excellent organization and operational skills including planning,
organizing and ability to motivate and lead others.
Ability to work in electronic document management systems, e.g.
High standards of integrity.
Demonstrated "Think out-of-the-box" mindset.
Strong sensitivity for a multicultural/multinational
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.
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.
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, Regulatory Affairs, Executive , Bridgewater, New Jersey
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