Director of Global Regulatory Operations

1 day ago

London, Greater London, United Kingdom Cpl Healthcare Full time

Director of Global Regulatory Operations

 

Cpl Healthcare is seeking a Director of Global Regulatory Operations to oversee the efficient operation of managing regulatory submission processes across the EU, UK, Switzerland, and Growth Market regions. This role requires strategic leadership, operational expertise, and a strong understanding of global regulatory requirements, especially in the EU, UK, and Switzerland.

This is an excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. You will be supported by an established team providing excellent career progression opportunities and a chance to work as a senior figure in the RA team.

Key Responsibilities:

  • Regulatory expertise relating to submissions requirements and standards for all ICH regions.
  • Strong pharmaceutical business experience managing staff, contracting, billing, and vendor relations.
  • Demonstrated experience in regulatory submissions management or regulatory operations, with focus on the EU/UK regions.
  • In-depth knowledge of EU/UK regulatory requirements, eCTD format, and the global submission process with the ability to manage complex projects, collaborate with cross-functional teams, and deliver results in fast-paced environments.
  • Proficiency with regulatory submission software and document management systems.
  • Excellent organizational and project management skills, with attention to detail and the ability to prioritize multiple tasks.
  • Strategic mindset with the ability to adapt to changing regulatory landscapes and operational demands.

This role comes with some excellent benefits including a bonus, car allowance, life assurance, pension scheme, and private healthcare.

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