Regulatory Affairs Manager

hace 2 semanas

Barcelona, Barcelona, España Innovaderm Research A tiempo completo

Job Summary:

The Regulatory Affairs Manager will be responsible for ensuring that all clinical trials conducted by Innovaderm Research are in compliance with applicable regulations and guidelines. This includes preparing and submitting regulatory documents, managing relationships with regulatory authorities, and ensuring that all trial-related activities are conducted in accordance with Innovaderm's standard operating procedures.

Key Responsibilities:

  • Prepare and submit regulatory documents, including Clinical Trial Applications and IRB/IEC packages
  • Manage relationships with regulatory authorities, including responding to queries and addressing concerns
  • Ensure that all trial-related activities are conducted in accordance with Innovaderm's standard operating procedures
  • Develop and implement regulatory strategies to ensure compliance with applicable regulations and guidelines
  • Collaborate with cross-functional teams, including clinical operations, to ensure that all trial-related activities are conducted in accordance with regulatory requirements

Requirements:

  • Bachelor's degree in life sciences or scientific discipline
  • At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry
  • 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

What We Offer:

  • A stimulating work environment and attractive advancement opportunities
  • A company benefits package
  • Ongoing learning and development

About Innovaderm Research:

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We are committed to providing equitable treatment and equal opportunity to all individuals. As such, we will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

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