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- Regulatory Affairs Consultant - CTA Submissions Experience Required!
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Regulatory Affairs Consultant - CTA Submissions Experience Required!
Parexel International Corporation
Istanbul, Istanbul, Turkey
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.
Responsibilities:
- 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. QualificationsSkills:
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
Education:
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!
Job posted: 2021-01-21