Senior Expert, Regulatory Science — Model-Enabled Development, RWE and Nove at Sanofi Aventis US LLC

Morristown, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

257833.33

Posted On

07 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategies, Model-Informed Drug Development, MIDD, Real World Evidence, Novel Endpoints, Health Authority Engagement, FDA, EMA, Modeling, Simulation, Clinical Development, Biostatistics, Knowledge Management, Risk Assessment, Pharmacometrics, Translational Medicine

Industry

Pharmaceutical Manufacturing

Description

Job title: Senior Expert, Regulatory Science — Model-Enabled Development, RWE and Novel Endpoints Location: Morristown, NJ About the Job Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. As a Senior Manager within our Global specialized Regulatory Science expert unit, you'll play a crucial role in developing innovative regulatory strategies that accelerate drug development through Model-Informed Drug Development (MIDD), Real World Evidence, and novel endpoint approaches. Working directly under Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints, you'll be responsible for hands-on project delivery, regulatory strategy submission, and direct engagement with health authorities on technical matters. This role offers the opportunity to work at the forefront of regulatory science innovation while collaborating closely with Global Regulatory Teams, Translational Medicine, Clinical Development, Biostatistics, and other key R&D functions. You'll contribute to establishing our team as a center of excellence by driving complex regulatory projects, supporting knowledge management initiatives, and helping build specialized capabilities across the organization. This position is ideal for a regulatory professional who thrives on technical challenges and wants to make a direct impact on bringing innovative medicines to patients faster. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives. Main Responsibilities Model-Enabled Regulatory Projects Regulatory Strategies: Lead and validate the regulatory strategies involving MIDD approaches, novel endpoints, and real-world evidence packages. Manage project timelines and deliverables for assigned therapeutic areas / development programs. Collaborate with Global Regulatory Leads (GRLs) to ensure strategies are appropriately integrated into overall projects regulatory plans. Support regulatory validation projects from execution through approval, ensuring alignment with R&D timelines and quality standards. Provides Direct Health Authority Engagement and Technical Support: Serve as a technical expert in interactions with regulatory agencies (FDA, EMA, and other global authorities) on modeling, simulation, RWE and novel endpoint topics. Prepare and present technical materials for regulatory meetings, including pre-submission meetings, scientific advice sessions, and advisory committee presentations. Support the development of health authority engagement strategies and maintain productive working relationships with agency reviewers and scientists. Drives Cross-Functional Collaboration and Project Delivery: Partner closely with Global Regulatory Teams, Translational Medicine, Clinical Development, Biostatistics, and Medical Affairs teams to ensure regulatory considerations are integrated early in development planning. Facilitate cross-functional working groups and project teams focused on MIDD implementation, RWE and endpoint development. Resolve technical and regulatory issues through collaborative problem-solving and provide regulatory guidance to support optimal study design and data generation strategies. Contributes to Knowledge Management and Capability Building: Develop and maintain best practices, standard operating procedures, and training materials for model-enabled regulatory approaches. Support the creation of case studies, lessons learned documents, and knowledge management platforms. Contribute to internal regulatory training programs and capability development initiatives. Monitor regulatory trends and agency guidance documents, providing regular updates to the team and broader organization on emerging opportunities and requirements. Supports Regulatory Strategy Development and Risk Assessment: Provide regulatory input and expertise for assigned projects and therapeutic areas, including risk assessment and mitigation planning. Support the development of regulatory strategy frameworks and contribute to strategic decision-making processes. Assist in evaluating new modeling approaches, endpoint technologies, and regulatory pathways for potential implementation across Sanofi's portfolio. Education: Bachelor's degree in quantitative science, health science or related field and 5+ years of either pharmaceutical or technology sector industry and/or academia with regulatory affairs experience and demonstrated expertise in drug development and regulatory submissions. Proven track record of successful regulatory interactions and submission preparation involving advanced analytical approaches. Direct experience with Model-Informed Drug Development (MIDD), RWE, pharmacometrics, modeling and simulation, or novel endpoint development is highly preferred Advanced degree (Masters, PharmD, PhD) in a quantitative science field (e.g., Pharmacometrics, Biostatistics, Pharmacology, Clinical Pharmacology, Computational Biology) or health sciences field preferred. Technical Expertise: Strong understanding of regulatory frameworks for model-enabled development (e.g., FDA MIDD Pilot Program, EMA modeling and simulation guidance). Knowledge of novel endpoint validation processes, biomarker qualification, and real-world evidence regulatory pathways. Experience with pharmacometric modeling, clinical trial simulation, or endpoint development is highly valued. Familiarity with regulatory agency thinking and current trends in regulatory science innovation. Communication and Collaboration Skills: Excellent written and verbal communication skills with the ability to translate complex technical concepts for diverse audiences. Proven ability to work effectively in cross-functional teams and build productive working relationships with internal and external stakeholders. Experience presenting to regulatory agencies and participating in scientific meetings is preferred. Project Management and Problem-Solving: Strong project management skills with the ability to manage multiple priorities and deliver high-quality work within tight timelines. Demonstrated analytical and problem-solving capabilities with attention to detail. Ability to work independently while contributing effectively to team objectives. Travel: 10% travel expected, domestic and international The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. 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 Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. North America Applicants Only The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The role involves leading and validating regulatory strategies utilizing Model-Informed Drug Development (MIDD), novel endpoints, and real-world evidence packages, while serving as a technical expert in direct engagement with global health authorities like the FDA and EMA. Responsibilities also include driving cross-functional collaboration across R&D teams and contributing to knowledge management and capability building within the regulatory science unit.