Global Regulatory Manager: Clinical Submissions Lead

Precision Medicine Group; Polska; On-site; PLN 190,000 - 285,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision Medicine Group in Poland seeks a Regulatory Manager to shape regulatory strategy across the clinical development life cycle, with emphasis on EU/US submissions and orphan/paediatric planning. You will coordinate submissions to Regulatory Authorities and Ethics Committees, lead regional/global teams and mentor Regulatory Affairs staff, while ensuring compliant, timely regulatory deliverables.

Role involves international collaboration, travel and staying current with regulatory guidance

Qualifications

• Bachelor’s degree in a scientific or healthcare field.
• 5 years regulatory experience for Manager level; 7 years for Senior Manager.
• Experience with regulatory affairs in CRO or pharmaceutical industry and leading clinical submissions.
• Knowledge of EU/US regulatory processes and submissions.

Responsibilities

• Provide regulatory strategy and guidance across the clinical development life cycle.
• Coordinate and prepare regulatory submissions to authorities and ethics committees.
• Lead regional or global regulatory submission projects.
• Oversee Regulatory Affairs Specialists to achieve submission targets.
• Maintain project plans and regulatory intelligence tools.
• Support regulatory staff development.
• Participate in regulatory strategy and timeline development for new studies.

Skills

Regulatory leadership

Regulatory lifecycle guidance

Cross-functional collaboration

English communication

Travel availability

Education

Bachelor’s degree in science/healthcare

Job description

Precision Medicine Group in Poland seeks a Regulatory Manager to shape regulatory strategy across the clinical development life cycle, with emphasis on EU/US submissions and orphan/paediatric planning. You will coordinate submissions to Regulatory Authorities and Ethics Committees, lead regional/global teams and mentor Regulatory Affairs staff, while ensuring compliant, timely regulatory deliverables.

Role involves international collaboration, travel and staying current with regulatory guidance