Regulatory Affairs Consultant - CTA Submissions Experience Required!

Istanbul, Turkey
14 Jan 2021
30 Jan 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

We are recruiting for a Regulatory Affairs Consultant, to be office based in Istanbul, Turkey. It is essential that you have experience with CTA within a regulatory team.

- Acting as a local regulatory contact representing various MAHs in Turkey, especially covering all MAs related maintenance activities
- Acting as a local regulatory contact for clinical trials in Turkey
- Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RAs in Turkey to ensure regulatory compliance, accuracy and completeness. Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.
- Interacting with Turkey regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.
- Preparation, review and approval of labels.
- After getting proper training acting as Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management.Qualifications

Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
Few years of experience in an industry-related environment

Minimum of a Bachelor's Degree in a Scientific or Technical Discipline

We encourage you to apply to this great opportunity! You will be rewarded with a competitive salary and bonus plan!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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