Manager Regulatory Affairs

NEW

Seeking a Manager of Regulatory Affairs to drive strategies that maximize regulatory success and enhance product development plans.

Job description:

Lead and support regulatory activities for assigned assets/projects
Present regional strategies to senior management
Monitor and interpret regional regulations affecting development and compliance
Provide expertise across development, registration, post-marketing, and life-cycle management
Review legislation, internal procedures, and fulfil post-marketing commitments
Build cross-functional and external partnerships to support access strategies
Communicate plans, timelines, and risks; ensure timely submissions/approvals
Prepare for and participate in Health Authority meetings and manage follow-up

Requirements:

BSc/BA in a scientific field (advanced degree preferred)
4+ years in drug regulatory affairs, ideally in EU/GEM markets
Knowledge of regulations for drugs/biologics across all development phases; skilled in Health Authority interactions
Advantage: experience with advanced therapies (cell & gene)
Strong analytical skills, attention to detail, and sound recommendations
Promotes inclusivity, empathy, and effective communication
Adapts well to change, builds strong relationships, and meets deadlines
Self-aware, resilient, and able to manage multiple challenges with energy and confidence