Regulatory Strategist
Company: Sanofi EU
Location: Morristown
Posted on: January 27, 2026
|
|
|
Job Description:
Job Title: Regulatory Strategist Location: Morristown,
NJ/Cambridge, MA About the Job Are you ready to shape the future of
medicine? The race is on to speed up drug discovery and development
to find answers for patients and their families. Your skills could
be critical in helping our teams accelerate progress. As a key
member of the Global Regulatory Team (GRT), and strategic partner
to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS)
leverages their regulatory expertise to contribute to the
definition of the global regulatory strategy, to enable and drive
the execution of aligned US, EU, and/or global regulatory strategy
for assigned projects, including Health Authority (HA)
interactions. The RS provides regulatory expertise and guidance on
procedural and documentation requirements to GRT and
cross-functional teams working flexibly within and across regions
to ensure the delivery of business objectives. We are an innovative
global healthcare company with one purpose: to chase the miracles
of science to improve people’s lives. We’re also a company where
you can flourish and grow your career, with countless opportunities
to explore, make connections with people, and stretch the limits of
what you thought was possible. Ready to get started? Main
Responsibilities : Enables the GRL by providing quality regulatory
input and position to internal business partners, including but not
limited to the clinical development teams, commercial and GRT for
assigned projects. Contributes to the GRT for assigned projects in
alignment with the ream's one regulatory voice for providing
strategic input on the Target Product Profile (TPP), business
planning, governance and committees. May be requested to lead GRT
meetings. Contributes to the development of the Global Regulatory
Project Strategy (GRPS) and ensures alignment with the core product
labeling for products in development as well as for lifecycle
management of products. May serve as a regional/local regulatory
lead and point of contact with HAs for projects/products in their
remit, as needed. Accountable for developing the HA engagement and
interaction plans for their assigned products, including the
authoring of the briefing document focused on the strategy and
scientific content, leading the team through meeting preparations
and moderating the meeting itself for the projects in their remit.
May lead HA meetings and preparations as designated. Leads
submission team or regulatory sub-team to ensure
NDA/BLA/MAA/Extensions filings meet the project timelines for
product launch and is responsible for the development and update of
the core global dossier/collaborates with regional lead where
region-specific submissions are applicable. Leads the IND/CTA
submission strategy to ensure preparation timelines meet the
project timelines for clinical trial initiation. Supports
operational and compliance activities for assigned deliverables,
develops, executes regulatory submission planning activities,
including generating submission content plans, submission tracking,
and document management utilizing the support and input of
cross-functional team and/or alliance partners where relevant.
About You Qualifications: BS/BA degree in a relevant scientific
discipline required. Advanced degree (PharmD, PhD, MD, or DVM or
MSc in Biology, Life Science, or related field) preferred. At least
6 years of relevant pharmaceutical/biotechnology experience,
including at least 4 years of relevant Regulatory Affairs
experience (regional and global), in early and late stage,
development of multiple modalities; experience within regulatory
CMC not directly applicable. Demonstrated experience with
preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing
documents and negotiating with a national/regional HA preferred.
Experience on multidisciplinary matrixed project teams (e.g.
clinical study team) preferred. Project leadership experience
preferred. Why Choose us : Bring the miracles of science to life
alongside a supportive, future-focused team.?? Discover endless
opportunities to grow your talent and drive your career, whether
it’s through a promotion or lateral move, at home or
internationally.?? Enjoy a thoughtful, well-crafted rewards package
that recognizes your contribution and amplifies your impact.?? Take
good care of yourself and your family, with a wide range of health
and wellbeing benefits including high-quality healthcare,
prevention and wellness programs and at least 14 weeks’
gender-neutral parental leave.? 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.
GD-SA LI-SA LI-Onsite vhd All compensation will be determined
commensurate with demonstrated experience. Employees may be
eligible to participate in Company employee benefit programs, and
additional benefits information can be found here.
Keywords: Sanofi EU, Bristol , Regulatory Strategist, Science, Research & Development , Morristown, Connecticut
