Regulatory Affairs CMC Project Lead

Sanofi•Morristown, NJ

5d•Onsite

About The Position

As Regulatory Affairs CMC Project Lead within our R&D team, you will serve as a strategic regulatory expert who coordinates multiple cross-functional projects, provides senior-level CMC regulatory guidance, mentors team members, drives accountability for deliverables, and influences decision-making while ensuring regulatory compliance and alignment within Sanofi's "Take the Lead" values. This role offers a dynamic opportunity at the intersection of regulatory expertise and innovative drug development. As part of this pioneering function, you'll provide strategic regulatory leadership across multiple projects, leveraging cutting-edge AI and digital platforms to accelerate development timelines. Working collaboratively with cross-functional teams, you'll influence critical decisions while mentoring colleagues in a diverse, inclusive environment that values every voice. This position offers exceptional growth opportunities through structured career paths and work-life balance, all while making a meaningful impact on millions of patients' lives through more effective and efficient drug development processes. 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.

Requirements

Minimum 6+ years of CMC regulatory strategy experience, including managing regulatory projects and interacting with health authorities
Experience guiding or mentoring junior staff, with a collaborative approach to developing team capabilities
Strong knowledge of CMC regulatory requirements in major markets and good understanding of pharmaceutical development and manufacturing processes
Effective communication and influencing abilities, with demonstrated success working in matrix environments and managing stakeholders
Ability to coordinate multiple projects simultaneously, prioritize effectively, and drive accountability for deliverables
B.S. or M.S. degree in a scientific discipline (advanced degree beneficial but not required)
Fluency in English (written and spoken)

Responsibilities

Coordinate multiple pharmaceutical projects, providing expert regulatory guidance while balancing priorities across different teams
Apply your technical knowledge of pharmaceutical manufacturing to develop regulatory strategies that navigate complex global requirements
Mentor and coach team members to build regulatory expertise across the organization, without having direct management responsibility
Solve complex regulatory challenges by interpreting regulations creatively and identifying both opportunities and risks
Lead health authority interactions and regulatory submissions, ensuring quality standards and deadlines are consistently met
Influence key decisions across projects through your regulatory expertise, even without formal authority
Foster collaboration across diverse teams while embodying Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold"