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Regulatory Affairs Manager

hace 2 meses

Madrid, Madrid, España Innovaderm Research A tiempo completo
Job Description

Job Title: Regulatory Affairs Manager

Job Summary:

Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable regulations, and good clinical practices.

Key Responsibilities:

  • Provide leadership on regulatory activities that lead to global startup of clinical trials
  • Plan and assign work, oversee the performance of direct reports, and perform annual reviews
  • Address employee relation issues and escalate concerns
  • Manage a team of Regulatory Affairs employees
  • Ensure adequate resources to sustain regional activities of the regulatory affairs group
  • Manage resource selection and onboarding processes for new employees
  • Ensure adequate training of the regulatory affairs group and oversee regulatory affairs practices
  • Ensure regulatory affairs' activities are delivered on time, within budget, and in compliance with SOPs and regulations
  • Identify and report out-of-scope activities to project teams
  • Develop regulatory affairs' practices, improvement initiatives, tools, processes, and training material to support departmental activities
  • Provide regulatory submissions strategic advice and may act as point of contact for Sponsors and subcontractors/project teams
  • Oversee resource assignments and participate in the preparation, review, submission, maintenance, and tracking of regulatory authority and IRB/IEC submissions
  • Ensure adequate review of activities performed outside of the company by subcontractors (e.g., partner CROs, vendors, consultants) to ensure high-quality standards before submission
  • Support project teams with oversight of submissions in global regions, such as Asia Pacific
  • Prepare and/or review master and country-specific Informed Consent form documents
  • Assist with the oversight of vendors supporting the department (e.g., central IRB, translation)
  • Oversee regulatory review of essential documents to authorize shipment of investigational product to clinical sites
  • Oversee labeling review of clinical trial drug supplies to ensure conformity with regional regulations requirements
  • Oversee the activities associated with clinical SAE reporting (tracking and submission to regulatory authorities, IRB/IEC, and Investigators)
  • Participate in the preparation and review of SOPs and associated tools
  • Ensure centralization of start-up global regulatory information and maintenance of the regulatory intelligence database
  • Participate in regulatory watch activities
  • Participate in bid defense meetings, project Kick-off meetings, audits, inspections, and other project-related meetings according to the company/client needs
  • Contribute to the development of project budgets for alignment with the scope of work and to the development of business development proposals to ensure the accuracy of regulatory submission information
  • Participate in function and/or corporate initiatives and special project assignments
  • Maintain familiarity with relevant current industry practices and regulatory requirements and guidelines
  • Maintain high-level knowledge about regional regulations in the area of company interest

Requirements:

  • Bachelor's degree (or equivalent) in life sciences or scientific discipline
  • At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry
  • Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages
  • Excellent knowledge of applicable regional/national country regulatory and IRB/IEC guidelines and regulations
  • Experience in team leadership; line management experience an asset
  • Excellent knowledge of Microsoft Office suite
  • Fluent in English with excellent oral and written communication skills; additional languages represent an asset
  • Ability to organize departmental work, prioritize different assignments, and work under pressure
  • Attention to detail and accuracy in work
  • Versatile and comfortable in a multitasking environment
  • Respect established timelines, expectations, priorities, and objectives
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines