Turkey Job Openings
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Regulatory Affairs Specialist
Ankara
FULL TIME
September 4, 2024
What you will be doing
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Clinical Trials: initial submission, lifecycle submissions: substantial amendments, notifications,
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Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissionsProviding input to the Regulatory Intelligence function.
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Reviewing Investigational Medicinal Product Dossier (IMPD)/ Investigator’s Brochure (IB) Core Docs and labeling for clinical trials.
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Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.
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Facilitating business development activities as needed
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Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
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Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechnlogy industry.
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Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.
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Familiarity with label review, translation requirements, and regulatory intelligence activities.
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Strong attention to detail and excellent communication skills.
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Various annual leave entitlements
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A range of health insurance offerings to suit you and your family’s needs.
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Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
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Life assurance
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Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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