Manager, Regulatory Affairs

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 obtainedSignificant contribution to the achievement of study start-up milestones by overseeing and managing high quality regulatory submissionsMonitor regulatory intelligences sources to ensure that the study remains in compliance throughout the lifecycle of the studyIdentify risks to milestone achievement and propose solutions to mitigate these risksDevelop and author study Submission Management PlanCreate and maintain study-specific regulatory trackers and document sharing methods to communicate information to internal and external stakeholdersAct as first point of contact for all regulatory related communications with the sponsor and internal study teamOrganize 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 discussedMaintain 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, includingclinical trial applications to regulatory authorities and ethics committees and import/export license applicationsDevelop and/or author country-specific Informed Consent FormsPerform Quality Check procedures on submissions, documents and trackersLead and coordinate responses to information requests from regulatory authorities or ethics committeesPerform the above activities during study start-up and throughout the lifecycle of the clinical trial withamendments, notifications, annual reports and end of trial submissions, ensuring compliance to ICH GCP, regional/local requirementsProblem solve and provide issue resolution to assist the team address unforeseen risks that have the potential to impact the successful delivery of the trialSupport revenue recognition and other budget-related activitiesRepresent the department during audits or inspections and address questions and issues raised by auditors or inspectorsMentor and train regulatory colleaguesRegulatory Services Delivery Oversight (35-40%)Main point of escalation for direct reports with Regulatory Study Lead responsibilities.Oversee and provide guidance on all regulatory aspects of a study, focusing on regulatory tracking, issue management, timelines and post-approval compliance (e.g., Annual Reporting, Notifications).Perform Quality Check procedures on submissions, documents and trackersStudy revenue recognition and financial management/budget support.Back-up and support direct reports with Regulatory Study and Country Lead responsibilities identified above.Team Management and Engagement (15 to 20%)Supervise, mentor, provide leadership and manage career and skill development of direct reports by supporting individual goals and objectives that align with department strategies and individual career ambitions and manage performance to ensure objectives are achieved.Provide line management for assigned direct reports, fostering an environment of curiosity, flexibility, empowerment, accountability and transparency. Encourage a growth mindset.Continuously gauge the pulse of direct reports and collaborate with other department leaders to evaluate department needs through training, learning and development and other engagement-related improvements.Process Improvements and Department Initiatives (15 to 20%)Identify and assess department needs and areas for improvement.Lead initiatives that are aligned with department and organizational objectives.Perform gap analyses in response to changing regulations and guidelines.Initiate change management activities when new or revised regulations and guidelines impact business processes.Subject matter expert for complex regulatory topics.Business Development Support (5-10%)Review proposals and study pricing as required.Participate in bid defenses as requested and when topics are included that align with areas of expertise.QUALIFICATIONS7 9 years of related experience(Honors) Bachelors degreeExpert knowledge of European regulations across clinical and commercial phasesCritical thinking and problem solvingManaging Direct ReportsStrong time management and organizational skillsFinancial and business acumenDifficult and complex communications (technical topics, performance and team engagement)Hands-on experience with regulatory submissions including and post-approval changesSkilled in regulatory project management, tracking timelines, deliverables, and dependencies across global teamsRegulatory intelligence and strategy able to interpret evolving guidelines and guide cross-functional teams accordinglyCollaborative across functions works closely with clinical, safety, and medical writing teamsDetail-oriented execution ensures accuracy, compliance, and consistency in all regulatory deliverablesStrong communication and risk assessment skills capable of defending regulatory positions with internal/external stakeholdersWorking Conditions Home-based*Accommodations for job applicants with disabilities are available upon request.PI5e9385c3b0ea-30511-39137041