Senior Regulatory & Submissions Specialist ( COMR ) FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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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