Regulatory Affairs Coordinator

1 week ago


Fatih, Istanbul, Turkey Er-Kim Full time

At Er-Kim, we are seeking a skilled Regulatory Affairs Specialist to join our team.

About the Role
  • This position is responsible for ensuring compliance with current Ministry of Health requirements for registration and variation files.
  • The ideal candidate will also be responsible for preparing food supplement dossiers according to current Ministry of Agriculture requirements.
  • Additionally, the successful candidate will prepare pricing submissions & reimbursement dossiers of products, sales permission dossiers, SmPC/PIL submissions, and answers to MOH's correspondences in due time.
Responsibilities
  1. Registration and Variation Files: Prepare and submit registration and variation files to regulatory authorities in accordance with current Ministry of Health requirements.
  2. Food Supplement Dossiers: Develop and maintain knowledge of current Ministry of Agriculture requirements for food supplement dossiers.
  3. Pricing Submissions: Prepare and submit pricing submissions & reimbursement dossiers of products to regulatory authorities.
  4. Sales Permission Dossiers: Prepare and submit sales permission dossiers to regulatory authorities.
  5. SmPC/PIL Submissions: Prepare and submit SmPC/PIL submissions to regulatory authorities.
  6. Correspondence: Respond to queries and correspondence from regulatory authorities in a timely and professional manner.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or Biology.
  • Advanced command of written and spoken English.
  • Proficiency in MS Office applications.
  • Excellent interpersonal, communication, and presentation skills.
  • Ability to work effectively in a team environment.
  • Good follow-up and strong planning skills.
  • No restriction for travel.


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