summary

i̇stanbul, istanbul (asia)
permanent

specialism
other
reference number
10642

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Managing artworks and packaging specifications via internal systems.
Archiving regulatory dossiers and official authority notifications.
Reviewing brochures, technical documents, and other materials prior to distribution.
Coordinating payments to competent authorities for regulatory matters.
Monitoring local regulatory changes and ensuring timely implementation.
Collaborating with global regulatory teams on cross-country projects.

We are looking for a Regulatory Affairs Lead to join our global partner, a company operating in the healthcare industry.
The role will be responsible for supporting regulatory operations and ensuring compliance with local and global requirements.

Preparing renewal, variation, and update dossiers for products.
Managing artworks and packaging specifications via internal systems.
Archiving regulatory dossiers and official authority notifications.
Reviewing brochures, technical documents, and other materials prior to distribution.
Coordinating payments to competent authorities for regulatory matters.
Monitoring local regulatory changes and ensuring timely implementation.
Collaborating with global regulatory teams on cross-country projects.

qualifications
Bachelor’s degree in a relevant field. (e.g. pharmacy, chemistry, chemical engineering or similar)
7 years of experience in regulatory operations.
Experience in pharmaceutical or related industries is a plus.
Knowledge of ERP systems. (preferably SAP)
Strong analytical and problem-solving skills with the ability to interpret data.
Proficiency in MS Office applications.
Solid understanding of operational processes related to regulatory activities.
Ability to work cross-functionally with departments such as Finance, HR, Sales Marketing, and Logistics.
Self-driven with the ability to prioritize tasks, report effectively, and escalate issues when necessary.
Strong project management skills, capable of handling multiple priorities.
Excellent command of English. (written and spoken)
Strong communication and interpersonal skills.
Willingness to travel if required.

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cemre erdem

cemre.erdem@randstad.com.tr

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regulatory affairs lead.

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cemre erdem

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