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Regulatory Affairs Director

hace 2 meses

Madrid, Madrid, España Innovaderm Research A tiempo completo
Job Title: Associate Director, Regulatory Affairs

About the Role:

We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our regulatory affairs group, you will be responsible for managing and overseeing the services provided by the Regulatory Affairs team in assigned regions.

Key Responsibilities:

  • Provide leadership on regulatory activities that lead to global start-up of clinical trials
  • Plan and assign work, oversee the performance of direct reports, and perform annual reviews
  • Address employee relation issues and escalate concerns as necessary
  • Oversee the preparation and submission of Clinical Trial Applications and IRB/IEC packages
  • Ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements

Requirements:

  • At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry, including 3 years in a management role
  • Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages
  • Solid knowledge of review and approval processes of applicable regulatory Health Authorities
  • Ability to assess impact of evolving information and provide guidance
  • Experience in team leadership and line management
  • Excellent knowledge of Microsoft Office suite and fluent in English with excellent oral and written communication skills

About Innovaderm Research:

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness.

What We Offer:

  • Flexible work schedule
  • Permanent full-time position
  • Company benefits package
  • Ongoing learning and development