Country Approval Specailist Fsp - Italy, France & Spain

PPD (Thermo Fisher) UK

United Kingdom
On-site
Coordinate local regulatory submissions
Liaise with investigators for submissions
Maintain trial status information
PPD (Thermo Fisher) is seeking a Country Approval Specialist for Italy, France, and Spain to manage and coordinate local regulatory submissions in alignment with global strategies. The ideal candidate will have a relevant degree, strong communication skills, and a minimum of two years of experience in regulatory affairs

Job Summary

  • Join a global team supporting top pharmaceutical companies in managing and preparing country regulatory submissions.
  • Play a key role in ensuring submissions are managed effectively and align with strategic goals, coordinating with internal departments for site start-up activities.
  • Maintain knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines applicable to services provided.

Matching Summary

Match Score: 85

PPD (Thermo Fisher) is seeking a Country Approval Specialist for Italy, France, and Spain to manage and coordinate local regulatory submissions in alignment with global strategies. The ideal candidate will have a relevant degree, strong communication skills, and a minimum of two years of experience in regulatory affairs.

Skills & Requirements

Must-have

  • Coordinate local regulatory submissions
  • Liaise with investigators for submissions
  • Maintain trial status information
  • Adhere to PPD/Client SOPs and guidelines

Nice-to-have

  • Develop country-specific patient documents
  • Assist with grant budget negotiations

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years of relevant experience
  • Effective communication skills
  • Strong attention to detail
  • Basic medical/therapeutic area knowledge
  • Basic knowledge of regulatory guidelines

Work Rights

Not specified

Tailored Resume

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