Country Approval Specialist - FSP (m/f/d)
Country Approval Specialist - FSP (m/f/d)
4 weeks ago0 Applicants

Join Us as a Country Approval Specialist

Become a key player in global regulatory excellence, supporting top pharmaceutical and biotech companies in optimizing clinical trials worldwide. As a Country Approval Specialist, you’ll engage in the management, preparation, review, and coordination of country submissions in line with global strategies.

What You’ll Do:

  • Prepare and coordinate local regulatory submissions under guidance, aligning with global strategies.
  • Offer local regulatory strategy advice to internal clients.
  • Coordinate project-specific local site initiation and activation services.
  • Serve as the key contact for ethical or regulatory submission-related activities at the country level.
  • Align submission activities with site start-up processes to meet PPD’s timelines.

Requirements:

  • Bachelor's degree or equivalent, with relevant experience.
  • At least 2 years of related work experience.
  • Proficiency in English and German languages.
  • Strong communication, interpersonal, and organizational skills.
  • Basic understanding of regulatory guidelines and EC regulations.

We offer an award-winning learning and development programme and a flexible working culture to support your professional and personal growth.

If you are aligned with our values of Integrity, Innovation, Intensity, and Involvement, apply now to help deliver safe and effective therapeutics globally!

Severely disabled applicants will receive preferential treatment when equally qualified.

Skills
Regulatory complianceProject CoordinationCommunication skillsGerman language proficiencyAttention to detail
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