Regulatory Submissions Manager - FSP ( Single Sponsor)
Istanbul, Türkiye Job ID R0000029602 Category Clinical TrialsAbout this Role
Parexel FSP is hiring for a Regulatory & Submissions Manager.
position in Istanbul. The position is hybrid office-based ( office 1 x per month).
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.
Are you ready to make a real impact on the success of our clinical trials? We’re seeking a talented individual to play a crucial role in ensuring performance and compliance with assigned protocols.
Dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases in animals and people.
Our sponsor has a long history of excellence in research and has delivered medicines, vaccines, and other health solutions for some of the world's most difficult diseases.
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.
· 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. We value your welfare just as highly as that of our patients.
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