Highly Experienced Clinical Regulatory Consultant

hace 1 semana


Madrid, Madrid, España Strago A tiempo completo

At STRAGO Healthcare, we seek a seasoned expert in clinical and regulatory affairs to lead our global drug development projects. As a Principal Consultant, you will provide strategic guidance on regulatory matters, ensuring alignment with global requirements and best practices.

The ideal candidate will have a strong background in clinical development and regulatory affairs, with a proven track record of successful regulatory submissions and approvals. They must be well-versed in regulatory processes and guidelines, including FDA, EMA, and ICH.

As a key leader, you will oversee clinical development activities, develop and execute global regulatory plans, and manage relationships with key regulatory bodies. Strong leadership, communication, and interpersonal skills are essential for success in this role.

We offer a dynamic and challenging environment where you can apply your expertise to drive successful project outcomes. If you are a motivated and experienced professional looking to make a meaningful impact, we encourage you to apply.

Key Responsibilities:

  • Provide strategic regulatory advice and support to project teams
  • Oversee all clinical development activities
  • Develop and execute a comprehensive global regulatory plan
  • Lead the development and implementation of the global agency interaction strategy
  • Cross-functional collaboration with internal and external stakeholders

Qualifications:

  • Advanced degree in Life Sciences, Clinical Research, or a related field
  • Minimum of 10+ years of experience in clinical development and global regulatory affairs
  • Proven ability to develop and implement global regulatory strategies in complex clinical programs


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