Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC Lead
Company: Sanofi
Location: Framingham
Posted on: March 13, 2026
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Job Description:
Job title: Global Regulatory Affairs (GRA) Chemistry,
Manufacturing and Controls (CMC) CMC Lead Location: Morristown, NJ,
Framingham, MA *This role does not offer international relocation
support 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. As GRA CMC Lead within our GRA CMC & GRA Device
Organization, youll drive global regulatory strategies for
pharmaceutical and vaccine products, collaborate with
cross-functional teams to navigate complex regulatory landscapes,
optimize product development and manufacturing processes, and
directly influence the success of drug approvals through strategic
negotiations with health authorities worldwide. Ready to get
started? Within Sanofi's Global Regulatory Affairs (GRA) CMC
organization, the CMC Lead role offers the opportunity to drive
regulatory strategy for pharmaceutical products and vaccines across
their lifecycle. Working at the intersection of science and
compliance, you'll develop CMC strategies, conduct risk
assessments, and serve as the primary liaison with regulatory
authorities including FDA and EMA. You'll collaborate across
R&D, Manufacturing, and Quality teams while preparing
high-quality regulatory submissions, managing compliance, and
anticipating regulatory trendsall contributing directly to bringing
innovative therapies to patients worldwide 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: Shape the
Future of Medicine: Guide products from early development to market
by creating smart regulatory strategies and working directly with
health authorities like FDA and EMA. Be a Problem Solver: Use your
expertise to spot potential challenges early, develop practical
solutions, and help teams navigate complex regulatory requirements.
Build Strong Relationships: Work closely with diverse teams across
R&D, Manufacturing, and Quality, fostering partnerships that
drive success. Make Smart Decisions: Assess risks and opportunities
for pharmaceutical products, helping teams make informed choices
that balance innovation with compliance. Drive Quality: Ensure
regulatory submissions meet high standards by reviewing technical
documents and providing strategic guidance to teams. Stay Ahead of
Changes: Keep up with evolving regulations and industry trends,
helping Sanofi anticipate and adapt to new requirements. Lead with
Impact: Use your voice to influence product development strategies,
while growing your expertise in a supportive, inclusive
environment. About You Experience: 6 years of CMC regulatory
experience with contributions to regulatory filings and
implementation of regulatory strategies; experience responding to
Health Authority questions. Regulatory Expertise: Experience
preparing regulatory documentation and familiarity with standard
submission processes Technical Knowledge: Understanding of
pharmaceutical development, manufacturing processes, and regulatory
requirements in major markets. Collaboration Skills: Ability to
work effectively in a matrix environment, engaging
cross-functionally with R&D, Manufacturing, and Quality teams.
Education: Bachelor's degree in a scientific discipline (Chemistry,
Biology, Pharmacy, or related field). Communication: Strong written
and verbal communication skills, with fluency in English.
Adaptability: Capability to manage multiple projects in a
fast-paced, hybrid work environment (60% on-site), with openness to
learning and growth. 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, Marthas Vineyard , Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC Lead, Science, Research & Development , Framingham, Massachusetts
