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Senior Regulatory Specialist - FSP ( Istanbul or Ankara)

Employer
Parexel
Location
Istanbul, Turkey
Salary
Competitive
Start date
14 Jun 2024
Closing date
27 Jun 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

REGISTER YOUR INTEREST for the upcoming Regulatory & Submissions Specialist positions in Istanbul or Ankara. As soon as the role becomes available, we will promptly send you an email invitation to officially apply. Thank you for your interest.

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. We value your welfare just as highly as that of our patients.

#LI-TA1

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word: 

Henry

 

 

Working With Heart™ - Christina's perspective:

Working With Heart™ - Christina's perspective:

 

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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