Senior Regulatory

2 days ago

Bhilai, Chhattisgarh, India PAREXEL International Ltd Full time ₹ 50,000 - ₹ 80,000 per year
Job Description

Parexel FSP is currently hiring Senior Regulatory & Submissions Specialist positions in Istanbul or Ankara.

Currently, the position is hybrid office-based.

Accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Experience required to be a fit for this role:
  • Mandatory - experience in EC and RA submission (ideally familiar with XML completion) including initial submission and protocol amendments submission.
  • Experience in Independently preparing submissions (CTC supports with document collection) to both EC and RA.
  • Experience in ICF preparation using templates.
  • Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
  • Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
  • Experience in validation of translated documents.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance.

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