Regulatory Manager / Senior Regulatory Manager - Remote

Overview

Precision for Medicine is seeking a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and guidance for clinical trials and related regulatory submissions across various European countries.

In Short

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile and review applications to Regulatory Authorities.
• Develop and review documents for regulatory submissions.
• Represent Global Regulatory Affairs in project team meetings.
• Lead projects for the region or globally.
• Coordinate Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans and regulatory intelligence tools.
• Assist in the development of Regulatory Affairs Specialists.
• Participate in corporate quality initiatives.
• Stay updated on regulations governing drug development.

Requirements

• Bachelor's degree in a scientific or healthcare discipline.
• 5-7 years of Regulatory experience.
• Computer literacy (MS Office/Office 365).
• Fluent in English.
• Experience in clinical submissions and knowledge of drug development processes.
• Ability to interpret clinical study results.
• Knowledge of clinical trials methodology.
• Availability for domestic and international travel.

Benefits

• Opportunity to work with a dynamic team in a growing organization.
• Contribute to groundbreaking cancer therapies.
• Continuous professional development.
• Flexible work environment.
• Employee appreciation initiatives.