Strategic Study Start-Up & Regulatory Lead

Ergomed Group; Lisboa; On-site; EUR 90,000 - 120,000; Full time

Job summary

Ergomed Group, a specialist CRO focused on rare diseases and oncology, seeks a Manager of Study Start Up and Regulatory Affairs in Lisbon to lead SSU and regulatory strategy for medium to high complexity trials. You will coordinate site initiation activities, negotiate agreements, manage timelines and budgets, and mentor junior staff while contributing to bids and proposals.

The role requires a graduate degree in Chemistry or Life Sciences and 6–8 years in pharma or CRO, with global project

Qualifications

• Experience leading regulatory strategy and SSU activities.
• Proven ability to manage global regulatory projects.
• Strong coaching and mentoring skills for junior team members.

Responsibilities

• Lead study start-up and regulatory activities for assigned projects.
• Coordinate and oversee SSU deliverables from site selection to initiation readiness.
• Negotiate and execute clinical site agreements and amendments.
• Monitor budgets, timelines, and resource allocation; escalate risks.
• Provide strategic regulatory guidance and contribute to bids and proposals.
• Mentor and develop junior staff; contribute to training.

Skills

Regulatory project management

Stakeholder management

Team coaching

Regulatory strategy

Education

Graduate degree in Chemistry or Life Sciences

Job description

Ergomed Group, a specialist CRO focused on rare diseases and oncology, seeks a Manager of Study Start Up and Regulatory Affairs in Lisbon to lead SSU and regulatory strategy for medium to high complexity trials. You will coordinate site initiation activities, negotiate agreements, manage timelines and budgets, and mentor junior staff while contributing to bids and proposals.

The role requires a graduate degree in Chemistry or Life Sciences and 6–8 years in pharma or CRO, with global project