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Manager Study Start Up and Regulatory Affairs

Ergomed · Posted Nov 11, 2026

Prague, Prague, Czech Republic
Manager
6–8 years

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The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness.

Responsibilities

Develop strategy based on regulatory requirements
Coordinate and oversee all SSU deliverables from site selection through site initiation readiness
Assist senior management in securing new business by participating in BDMs and contributing to proposals/budgets
Provide strategic regulatory guidance, training, coaching and mentoring to junior members
Line manage members of staff

Requirements

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent

Skills

Regulatory Affairs Study Start-Up Project Management Global Projects Risk Mitigation Negotiation Stakeholder Management

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