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Regulatory Affairs Director

hace 2 meses

Madrid Centro, Madrid, España Innovaderm Research A tiempo completo
Job Summary

The Senior Manager, Regulatory Affairs will be responsible for overseeing the regional regulatory affairs department at Innovaderm Research, ensuring that all services are conducted in accordance with the company's standard operating procedures, applicable regulations, and good clinical practices.

Key Responsibilities
  1. Leadership and Strategic Planning
  • Provide leadership on regulatory activities that lead to global startup of clinical trials.
  • Plan and assign work, oversee the performance of direct reports, and conduct annual reviews.
  • Address employee relation issues and escalate concerns.
Regulatory Compliance and Risk Management
  • Ensure adequate resources (headcount, experience, training) 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 to ensure alignment of practices across the team.
Regulatory Submissions and Communications
  • Manage regulatory submissions strategic advice and 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.
Global Regulatory Oversight
  • 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).
Regulatory Review and Quality Assurance
  • Oversee regulatory review of essential documents to authorize shipment of investigational product to clinical sites.
  • Oversee labelling 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).

Requirements

  1. Experience as a lead and escalation point of contact for global projects.
  2. At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry.
  3. Experience with oversight of preparing and submitting part I and/or part II Clinical trial applications following EU CTR.