Regulatory Strategist - mRNA Vaccines
Company: Sanofi
Location: Swiftwater
Posted on: April 25, 2025
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Job Description:
Job Title: Regulatory Strategist - mRNA Vaccines
Location: Swiftwater, PA or Morristown, NJ
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.
Sanofi has established an mRNA Center of Excellence (CoE) and is
actively developing mRNA-based vaccines which have the potential to
be first and best-in class products in Influenza, Acne, Chlamydia
and Respiratory Syncytial Virus (RSV). The Regulatory Affairs mRNA
team is responsible for developing and executing cutting-edge
regulatory strategies that enable successful product development
and market access, while ensuring compliance with evolving global
regulations specific to mRNA technologies. The team serves as the
critical interface between R&D, manufacturing, and Health
Authorities to navigate the unique regulatory challenges of this
innovative therapeutic platform. The position is within the mRNA
Therapeutic Area, reporting to Global Regulatory Lead.
As a key member of the Global Regulatory Team, the mRNA Regulatory
Strategist is a strategic partner to contribute to the definition
and execution of innovative regulatory approaches to accelerate the
development and approval of two mRNA vaccine candidates while
navigating the evolving regulatory landscape for this cutting-edge
technology. This role requires a strategic mindset to balance
scientific innovation with regulatory challenges.
We are an innovative global healthcare company that helps the world
stay ahead of infectious diseases by delivering more than 500
million vaccine doses a year. Across different countries, our
talented teams are exploring new technologies to protect people and
promote healthy communities. We chase the miracles of science every
single day, pursuing progress to make a real impact on millions of
patients around the world.
Main Responsibilities
- The Regulatory Strategist (RS) enables the Global Regulatory
Lead (GRL) providing quality regulatory input and position to
internal business partners, including but not limited to the
clinical development teams and the Global Regulatory Team for
assigned projects
- The RS liaises with clinical, medical, commercial, and other
internal business stakeholders to enable successful regulatory
outcomes
- The RS contributes to the development of a harmonized, one
regulatory voice for providing strategic input through
participation in appropriate governance committees and forums at
the direction of the GRL
- The RS may represent Global Regulatory Team strategic position
on behalf of the GRL at regulatory forums/committees at request of
GRL
- The RS serves as point of contact with Health Authorities for
vaccine candidates in his/her remit in US
- The RS contributes to the development of global Health
Authorities engagement and interactions plans for their assigned
products in collaboration with the regulatory and cross-functional
team members. This includes the authoring of the briefing document
focused on the strategy and scientific content, and leading the
cross-functional team through meeting preparation. The RS attends
and may lead Health Authorities meetings as designated
- The RS identifies regulatory risks and proposes mitigation
plans to cross-functional teams as appropriate
- The RS ensures alignment between the Regulatory Strategy and
the core product labeling for vaccine candidates in his/her
remit
- The RS leads submission team or regulatory sub team to ensure
regulatory filings meet the project timelines
- The RS may lead the IND/CTA submission strategy to ensure
preparation timelines meet the project timelines for clinical trial
initiation
- The RS contributes to content and review of regulated documents
(IB, PBRER, DSUR, RMP, etc)
- The RS supports operational and compliance activities for
assigned deliverables, develops, executes
- regulatory submission planning activities, including generating
submission content plans, submission tracking, and document
management
- The RS participates in the development and monitoring of the
global regulatory environment
About You
Knowledge, Skills & Competencies:- Proactively contributes with curiosity and openness to diverse
perspectives
- Demonstrated ability to handle multiple products/deliverables
simultaneously
- Demonstrates business acumen, leadership, influencing and
negotiation skills
- Effective communication skills, specifically strong oral and
written presentation skills
- Understanding of clinical development of drugs, biological
products. Vaccines is a plus
- Ability to work in electronic document management systems,
e.g., Veeva Vault is a plus
- Strong sensitivity for a multicultural/multinational
environment.
Experience & Education:- 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 8 years prior pharmaceutical/biotechnology industry
experience, including at least 5 years of relevant Regulatory
Affairs experience (regionally and/or global)
- Significant track record of US regulatory expertise required
(demonstrated experience with preparation of BLA/NDA, INDs, FDA
meeting briefing documents)
- Previous experience with novel technology platforms and/or
accelerated regulatory pathways would be a plus
- 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-SP
#LI-SP
#LI-Onsite
#vhd
#mRNA
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.PandoLogic. Keywords: Compliance Manager, Location: Swiftwater, PA - 18370 , PL: 597424970
- Bring the miracles of science to life alongside a supportive,
future-focused team.
- 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
- Proactively contributes with curiosity and openness to diverse
perspectives
Keywords: Sanofi, Bloomfield , Regulatory Strategist - mRNA Vaccines, Other , Swiftwater, New Jersey
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