Regulatory Affairs Executive

Eklendi 12/11/2026

Gain exposure to end-to-end regulatory and lifecycle activities.
Opportunity to broaden your regulatory affairs expertise.

Müşterimiz Hakkında

Our client is a well-established pharmaceutical company with a diversified product portfolio in the Turkish market. We are currently seeking a Regulatory Affairs Executive to join their team.

İş Tanımı

Manage the preparation, submission, and maintenance of regulatory dossiers for pharmaceutical products and food supplements.
Lead registration, renewal, variation, and post-approval submission activities.
Coordinate eCTD dossier preparation and submissions for imported products.
Handle regulatory correspondence with <TİTCK> and coordinate responses to inquiries and deficiency letters.
Ensure CTD modules are complete and compliant with applicable regulations.
Work closely with Quality, Medical, R&D, Marketing, Manufacturing, and Pharmacovigilance teams.
Support pricing, reimbursement, GMP, and post-approval regulatory processes.

Aradığımız Profil

A successful Regulatory Affairs Executive should have:

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biology, Molecular Biology, Biomedical Engineering, or a related Life Sciences discipline.
Minimum 8 years of Regulatory Affairs experience within the pharmaceutical industry.
Hands-on experience in registration, variation, renewal, and lifecycle management activities.
Experience with eCTD dossiers and imported product registrations.
Good command of English.
Strong communication, planning, and stakeholder management skills.
Experience with reimbursement and pricing dossiers will be considered an asset.