Senior Manager, Study Start-Up & Regulatory Affairs

Ergomed Group; Kraków; On-site; PLN 180,000 - 280,000; Full time

Job summary

Ergomed Group is seeking a Manager of Study Start Up and Regulatory Affairs to lead SSU and regulatory activities for complex trials. You will coordinate site selection through initiation readiness, ensuring timely, compliant delivery while supporting growth opportunities.

You will provide strategic regulatory guidance, mentor junior staff, and contribute to bids and budgets. A graduate degree in Life Sciences and 6–8 years in pharma/CRO with 3 years in leadership is required.

Qualifications

• Graduate degree in Chemistry or Life Sciences (or equivalent).
• 6–8 years in pharmaceutical/CRO, with at least 3 years in leading/project management roles.

Responsibilities

• Lead SSU and regulatory activities for projects of medium to high complexity, ensuring delivery on time and to quality standards.
• Coordinate site selection, initiation readiness, and regulatory deliverables; negotiate and execute site agreements as required.
• Provide strategic regulatory guidance, coaching, and mentoring to junior staff; participate in BDMs, proposals, and budgets.

Skills

Regulatory affairs

Project management

Team leadership

Education

Graduate degree in Life Sciences

Job description

Ergomed Group is seeking a Manager of Study Start Up and Regulatory Affairs to lead SSU and regulatory activities for complex trials. You will coordinate site selection through initiation readiness, ensuring timely, compliant delivery while supporting growth opportunities.

You will provide strategic regulatory guidance, mentor junior staff, and contribute to bids and budgets. A graduate degree in Life Sciences and 6–8 years in pharma/CRO with 3 years in leadership is required.