Manager Regulatory Affairs
Company: Sanofi
Location: Cambridge
Posted on: March 22, 2026
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Job Description:
Job Title: Manager Regulatory Affairs Location: Morristown, NJ
Cambridge, MA About the Job Join the engine of Sanofis mission
where deep immunoscience meets bold, AI-powered research. In
R&D, youll drive breakthroughs that could turn the impossible
into possible for millions. With some direction from the
Therapeutic Area Head, will conduct the independent review of
advertising, promotional, communications and other materials, and
help develop and implement regulatory strategies for promotion and
advertising campaigns, including serving as regulatory lead for
product launches. As the product A&P expert, contribute to the
development and implementation of regulatory strategies for
labeling, product defense, and development projects. Serve as the
primary liaison with FDA, for assigned products, on matters related
to advertising and promotional compliance matters. About Sanofi:
Were an R&D-driven, AI-powered biopharma company committed to
improving peoples lives and delivering compelling growth. Our deep
understanding of the immune system and innovative pipeline enables
us to invent medicines and vaccines that treat and protect millions
of people around the world. Together, we chase the miracles of
science to improve peoples lives. Main Responsibilities: Identifies
product specific or therapeutic area A&P issues and works with
other teams to propose and implement solutions. Identifies
different strategies for addressing issues; advises of risk/benefit
of each and assists clients with making sound business decisions
with the understanding of the potential risk/benefits with respect
to intervening regulatory matters. Oversees and bears
responsibility for the successful implementation of regulatory
strategic objectives and projects with minimal supervision. Active
participant and Regulatory representative on brand teams and Review
Committees (RC) for commercial and medical materials, respectively.
Provides guidance and feedback to internal Sanofi constituencies
(commercial groups, R&D) to maximize the competitive impact of
product development as well as ultimate promotion, advertising, and
reimbursement. Provides input to the Global organization on
domestic regulatory strategies for in-line products through life
cycle management programs. Contribute A&P expertise to the
development of optimal labeling on new and supplemental new drug
applications. Provides product-specific Regulatory strategies to
mitigate risk; works in conjunction with brand team management to
provide advice and risk/benefit analysis to maximize value to
stakeholders. Performs other duties as assigned. About You Basic
Qualifications: Bachelors degree in Life Sciences from an
accredited four-year college or university. Work Experience
Required: 1-3 Years experience in the following areas: Experience
within pharmaceutical or medical device Regulatory Affairs.
Successful track record with ideally 1-3 years relevant regulatory
experience. Dealt effectively with cross-functional groups, which
may include Medical, Legal, Marketing etc. Knowledge, Skills and
Equivalent Experience: Knowledge and understanding of complex
medical and scientific subject matter. Ability to work well within
cross-functional teams. Demonstrates solid oral communication and
writing skills. Understanding of the U.S. pharmaceutical
marketplace, and familiarity with medical terminology. Understands
issues, problems and opportunities by comparing data from different
sources to draw conclusions and then can choose a course of action
or develop the appropriate solution. Develops collaborative
relationships to facilitate the accomplishment of work goals.
Develops and proposes innovative solutions in work situations,
trying different and novel ways to deal with work problems and
opportunities. Shows ability to use appropriate interpersonal
styles and techniques to gain acceptance of ideas or plans. Can
build collaborative internal networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values
consistent with the Sanofi values. Is able to balance projects with
day-to-day duties, ensuring participation from other members of the
department as needed. Is able to establish priorities and timelines
to effectively manage workload. Is able to multi-task well. Deals
with people in an honest and forthright manner representing
information and data accurately. 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 its 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, Weymouth , Manager Regulatory Affairs, Science, Research & Development , Cambridge, Massachusetts
