Associate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety)

📋 Description

• Monitor regulatory compliance activities, including SmPC updates, Reference Safety Information
• Ensure Regulatory Affairs documentation remains accurate, current, and complete within the Trial
• Monitor Regulatory Affairs training compliance and partner with Corporate Training to maintain
• Oversee timely updates to Regulatory Affairs SOPs, procedures, standards, and study-specific
• Monitor and analyze key compliance metrics, identify trends and risks, and contribute to leadership
• Support quality event investigations, including deviation assessments, root cause analysis

🎯 Requirements

• Bachelor’s degree in a related discipline with at least 11 years of relevant experience, or a
• 7–10 years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience supporting audits and regulatory inspections is preferred.
• Strong knowledge of regulatory frameworks, pharmaceutical industry practices, and regulatory
• Ability to develop and manage plans, establish timelines, define performance standards, and
• Strong analytical and problem-solving skills, with the ability to assess trends, risks, operational

🎁 Benefits

• Annual base salary range of $163,000–$231,000, with the final offer adjusted based on geographic
• 401(k) plan with company contributions.
• Medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Eligibility for a discretionary annual bonus program.