Remote Global Regulatory Manager

Precision Medicine Group; Warszawa; Remote; PLN 190,000 - 285,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory meetings, orphan designations, paediatric planning, and accelerated procedures. You will coordinate and prepare documentation for submission to Regulatory Authorities and Ethics Committees, ensuring compliance and timely submissions.

The role requires CRO or pharmaceutical industry experience and ability to travel

Qualifications

• Bachelor's degree or equivalent experience in a scientific or healthcare discipline
• 5 years regulatory experience for Manager level and 7 years for Senior Manager level
• Regulatory affairs experience in CRO or Pharmaceutical Industry; leadership of clinical submissions

Responsibilities

• Provide regulatory strategy for clinical trials and regulatory meetings
• Coordinate and prepare regulatory submissions to authorities and ethics committees
• Lead and coordinate Regulatory Affairs Specialists to meet submission targets
• Contribute to regulatory strategy and timelines for new study opportunities
• Maintain regulatory intelligence and project trackers

Education

Bachelor's degree

Job description

Precision Medicine Group is seeking a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory meetings, orphan designations, paediatric planning, and accelerated procedures. You will coordinate and prepare documentation for submission to Regulatory Authorities and Ethics Committees, ensuring compliance and timely submissions.

The role requires CRO or pharmaceutical industry experience and ability to travel