[Urgent] Associate Director, Global Regulatory Affairs - Global Labeling Strategy
Company: Sanofi
Location: Morristown
Posted on: July 2, 2025
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Job Description:
Job Description Job Title: Associate Director, Global Regulatory
Affairs – Global Labeling Strategy Location: Morristown, NJ or
Cambridge, MA (Hybrid) 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.
The Associate Director, Global Regulatory Affairs – Global Labeling
Strategy is responsible for leading the development, maintenance,
and implementation of global labeling strategy for assigned
products, including those in clinical development, life cycle
management (LCM), and the marketed portfolio. This role leads the
creation and update of core labeling documents (e.g., Company Core
Data Sheet) and regional labeling (e.g., US Prescribing
Information, EU SmPC), ensuring alignment with regulatory
requirements and Sanofi’s product positioning. The Associate
Director contributes to early development activities by providing
regulatory input into clinical development plans, including
guidance on Phase 2 and Phase 3 protocols, recommendation for the
selection of endpoints relevant for labeling and consideration of
patient experience data (e.g., Patient Reported Outcomes, quality
of life measures). This strategic input ensures alignment between
clinical evidence generation and future labeling opportunities
aligned with the Sanofi “Label as a driver” philosophy. The
Associate Director collaborates closely with cross-functional
teams, including Global Regulatory Affairs, Clinical Development,
Safety, and Medical Affairs, to ensure labeling content reflects
scientific integrity, regulatory compliance, and supports safe and
effective product use. 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 - Lead
the preparation, review, and maintenance of global labeling
strategy and content (CCDS, USPI, SmPC) for assigned products
throughout their lifecycle. - Collaborate with clinical, medical,
safety, and regulatory colleagues to provide labeling input
relevant to clinical study protocols, especially in early and late
development phases. - Contribute to discussions around clinical
endpoint selection and integration of patient experience data to
maximize labeling value. - Assist in labeling submissions,
regulatory queries, and updates to ensure compliance with
regulatory expectations and company standards. - Support alignment
between core global labeling and regional/local labeling
requirements. - Participate in cross-functional regulatory teams
and labeling governance processes. - Stay informed of relevant
regulatory guidelines, industry trends, and competitor labeling
activities. - Provide mentoring and training to more junior
labeling strategists and support process improvements within the
labeling function. About You COMPETENCES - Strong knowledge of
global regulatory labeling requirements, particularly US and EU. -
Ability to interpret clinical data and protocols with respect to
regulatory labeling implications. - Collaborative communication
skills and ability to work effectively across functions. -
Attention to detail and organizational skills to manage multiple
deliverables. - Proactive approach with the ability to work
independently and under supervision. - Strong stakeholders’
management skills. EXPERIENCE - Advanced degree (PharmD, PhD, MD,
or MSc) in life sciences, pharmacy, or medically related field. -
Minimum 5 years of pharmaceutical industry experience, with at
least 3 years in Regulatory Labeling. - Experience supporting
labeling strategy in development and/or marketed products. -
Familiarity with clinical protocol development and regulatory
labeling expectations. - Exposure to patient experience data and
its regulatory relevance is advantageous. - Experience mentoring or
guiding junior colleagues is a plus. 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-Hybrid 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, East Orange , [Urgent] Associate Director, Global Regulatory Affairs - Global Labeling Strategy, Science, Research & Development , Morristown, New Jersey