Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)

When our values align, there's no limit to what we can achieve.
 

Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. In this role, you will help ensure our clients’ investigational, new, and marketed small‑molecule and biologic products are developed and maintained in full alignment with global regulatory requirements. Your primary geographic focus will include the United States, European Union, and Canada, with an emphasis on enabling timely approvals and supporting sustained market access.

You will contribute to both operational execution and strategic regulatory planning, working across a diverse portfolio of programs. The ideal candidate thrives in a collaborative environment and brings a balanced blend of hands‑on authoring expertise and forward‑looking regulatory insight.

Key Responsibilities

Strategic CMC Leadership

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