Global Regulatory Compliance Lead - Remote

Overview

The Global Regulatory Compliance Lead is responsible for leading assigned Regulatory Compliance activities, including but not limited to activities related to the procedural document creation and updates, audit and inspection execution and preparation and regulatory risk management.

In Short

• Lead assigned Regulatory Compliance work and improvement activities
• Act as Quality Training Contributor (QTC) for the department
• Manage onboarding and exit activities for employees and consultants
• Lead procedural documents creation and updates
• Act as Global Process Owner for assigned procedures
• Manage GRA Business Contingency Plan responsibilities
• Lead preparations and execution of audit and inspection activities
• Follow up on change control, deviations and continuous improvement activities
• PSMF responsible within Global Regulatory Affairs
• Support regulatory compliance activities in acquisitions and integrations

Requirements

• Experience from Life Science/pharmaceutical industry
• Experience from quality-, regulatory- or pharmacovigilance related work
• Experience from regulatory compliance and process management is a plus
• Experience working in a global environment
• Strong track record of leading projects and collaborating effectively
• Strong coordination skills
• Proficiency in MS-Office Suite
• Fluency in English, additional language skills are a plus
• Strong attention to detail and focus on quality
• Excellent organizational and time management skills

Benefits

• Competitive compensation
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact on patients