Manager, Regulatory Affairs (Europe)

Manager, Regulatory Affairs (Europe)

Management of Regulatory Affairs personnel through line management and project delivery oversight. Responsible for developing study regulatory strategies and leading department initiatives. The role involves collaboration with other departments to support the successful approval of clinical trials. May have regional-specific responsibilities, e.g., Manager, Regulatory Affairs Europe.

Regulatory Study and Country Lead (10-15%)

• Review study protocols and informed consent forms to ensure that documents are compliant with applicable regulatory standards and that regulatory and operational risks are minimized.
• Manage and review the translation of drug labels in collaboration with sponsors and third-party vendors.
• Support study regulatory strategy by :
• Management of regulatory aspects of the study, ensuring required approvals are obtained
• Significant contribution to the achievement of study start-up milestones by overseeing and managing high quality regulatory submissions
• Monitor regulatory intelligences sources to ensure that the study remains in compliance throughout the lifecycle of the study
• Identify risks to milestone achievement and propose solutions to mitigate these risks
• Develop and author study Submission Management Plan
• Create and maintain study-specific regulatory trackers and document sharing methods to communicate information to internal and external stakeholders
• Act as first point of contact for all regulatory related communications with the sponsor and internal study team
• Organize and lead regulatory meetings with internal and external stakeholders and participate in cross-functional study team meetings, ensuring that timely regulatory updates and issues are discussed
• Maintain efficient collaboration and relationship with external vendors responsible for study applications and oversee tasks delegated to them.
• Prepare, execute, and / or oversee submissions as described in the Submission Management Plan, including
• clinical trial applications to regulatory authorities and ethics committees and import / export license applications
• Develop and / or author country-specific Informed Consent Forms
• Perform Quality Check procedures on submissions, documents and trackers
• Lead and coordinate responses to information requests from regulatory authorities or ethics committees
• Perform the above activities during study start-up and throughout the lifecycle of the clinical trial with
• amendments, notifications, annual reports and end of trial submissions, ensuring compliance to ICH GCP, regional / local requirements
• Problem solve and provide issue resolution to assist the team address unforeseen risks that have the potential to impact the successful delivery of the trial
• Support revenue recognition and other budget-related activities
• Represent the department during audits or inspections and address questions and issues raised by auditors or inspectors
• Mentor and train regulatory colleagues

Regulatory Services Delivery Oversight (35-40%)

Team Management and Engagement (15 to 20%)

Process Improvements and Department Initiatives (15 to 20%)

Business Development Support (5-10%)

QUALIFICATIONS

Working Conditions

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