Launch Acceleration and Regulatory Enablement Lead
Sanofi · Morristown, New Jersey, United States
Job title: Launch Acceleration and Regulatory Enablement Lead
- Location: Morristown, NJ/Cambridge, MA
About the job:
Innovation doesn't happen by doing more of what we've always done. This role is for a regulatory professional who is ready to challenge assumptions, question what we've stopped questioning, and help us accelerate how we bring medicines to patients. You will be part of building something new - a function that transforms how Sanofi conceives, builds, and delivers regulatory submission and obtains authorizations – our mission is to create awareness, clarity and capabilities that enable teams to make better choices to accelerate regulatory authorizations.
What makes this role unique:
- You will help build a brand-new function from the ground up.
- You will directly impact how Sanofi brings medicines to patients faster.
- You will work across all Global Business Units and submission – your impact is not limited to one product or one team.
- You will be part of a small, high-impact team where your contribution is visible and valued.
This role is responsible for leading and delivering submission acceleration initiatives across all Global Business Units – building the awareness, tools, processes training and capabilities that make every submission faster, smarter, and more seamless. This is not a submission execution role. The Lead is a thought leader and subject matter expert on regulatory submission strategies, an energetic communicator equally comfortable at senior governance forums and hands-on training sessions, and a connector who works across functions and TAs to modernize how Sanofi conceives, builds, and delivers regulatory submissions.
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.
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:
1. Lead Submission Acceleration
- Develop and drive tangible submission acceleration strategies and levers in close collaboration with cross-functional R&D Global Project Team functions and submission teams, aligning with portfolio priorities and regulatory opportunities (e.g. regulatory facilitated pathways, Access Consortium, Accumulus).
- Define and embed end-to-end submission preparation best practices – creating tools, templates and guidance that enable project teams to achieve early readiness across all Global Business Units - embedding acceleration principles from the earliest stage of development planning through to delivery.
2. Training
- Training & Change Management Delivery
- Design and deliver engaging training sessions on submission acceleration tools, processes, and mindset shifts across Global Regulatory Teams and R&D cross-functional Global Project Teams - making acceleration easy and accessible for every function.
- Co-develop the change management toolkit, coaching teams through new ways of working and removing roadblocks.
- Act as a confident, energetic influencer and presenter - bringing technical content to life for varied audiences, from working teams to senior stakeholders.
3. Modular Content & Knowledge Reuse
- Drive strategies and standards for modernisation of modular regulatory content components (CTD modules, core dossier sections, bridging documents) - identifying opportunities for reuse and ensuring content is built for scale across products, indications, and lifecycle events.
- Apply single-source-of-truth principles to ensure consistency of scientific and regulatory messaging across CMC, Clinical, Nonclinical, and Safety content.
- Support the development and maintenance of global core dossier templates and standards and ensure incorporation in regulatory new marketing authorisation processes.
- Regulatory Intelligence & Outside-In Thinking
- Monitor evolving health authority expectations, guidance documents, and industry best practices relevant to dossier development, submission innovation and launch acceleration.
- Brings an outside-in mindset, deliberately borrowing from nontraditional, high-velocity industries to design faster, more scalable, and more resilient regulatory operating models
- Translate external regulatory intelligence into actionable insights for the team and cross-functional partners.
4. Process Innovation & Operating Model Support
- Co-design and run pilots, proof-of-concepts across acceleration levers – bringing hands-on regulatory submission expertise. Identify bottlenecks, testing practical solution and leading rollout of improved processes according to regulatory quality standards and business priorities.
- Contribute to the adoption of AI, automation and digital tools within dossier workflows, partnering with Digital and Data teams as a regulatory subject matter expert.
- Contribute to the development of a Submission Excellence Platform - a one-stop-shop for submission excellence for all involved functions.
- May act as Global Process Lead for New Marketing Authorisation processes.
5. Cross-Functional Collaboration & Stakeholder Partnership
- Serve as the go-to acceleration partner for Global Regulatory Leader and the cross-functional R&D Global Project Team and members across all TAs (CMC, Clinical, Nonclinical, Safety, Commercial, Translational Medicine Unit and Quality colleagues) providing guidance and hands-on support to help them execute faster submissions.
- Independently prepare and present materials for senior R&D governance forums, and internal decision-making bodies.
- Co-lead the cross-functional R&D Submission Excellence network - acting as a connector and enabler across TAs and stakeholder functions.
6. Quality & Compliance Readiness·
- Own metrics and KPI tracking to monitor speed, predictability, quality, and reuse - enabling early intervention and continuous improvement.
About you
Experience:
- Bachelor's degree in a Life Sciences, Pharmacy, Chemistry, a Scientific discipline or a related field
- Advanced degree (MSc, PhD, PharmD) preferred.
- 10+ years of experience in Global Regulatory Affairs, with demonstrated expertise in leading global regulatory submission preparation and execution team(s).
- Solid understanding of global regulatory frameworks (ICH guidelines, EU, US FDA, and other major health authority requirements).
- Hands-on experience with lifecycle management submissions (variations, renewals, line extensions) across multiple regions.
- Familiarity with modular dossier architecture, content reuse strategies, and submission planning tools.
- Experience in delivering results in matrixed, cross-functional environments with multiple simultaneous workstreams.
- Exposure to or interest in process improvement, agile methodologies, or digital/automation tools applied to regulatory workflows is a strong asset.
Competencies:
- Global Regulatory Strategy: Understands the global regulatory landscape across major health authorities (FDA, EMA, PMDA and others) and applies strategic thinking to accelerate submission planning, anticipate regulatory risks, and align dossier development with portfolio priorities and health authority expectations.
- Training & Facilitation: Designs and delivers engaging training sessions; energizes audiences and builds capability across functions.
- Executive Presence: Communicates with clarity, confidence, and credibility at all levels.
- Leading Without Authority: Drives alignment, commitment, and action across functions and seniority levels without direct reporting lines - building trust, influencing through expertise and relationships, and holding others accountab