Regulatory Affairs Specialist

3 days ago


Istanbul, Istanbul, Turkey Proceutica İlaç Paz. ve Dan. A.Ş. Full time ₺50,000 - ₺80,000 per year

About Us:

Proceutica is a pharmaceutical company established in 2008, specializing in rare diseases and orphan drugs. Through strong global partnerships, we provide innovative therapeutic solutions to support patients with unmet medical needs. With a dynamic structure and a commitment to high ethical standards, we continue to expand our presence in the healthcare industry.

We are looking for a
Regulatory Affairs Specialist
to join our growing team in Turkey. The ideal candidate will play a key role in marketing authorization processes, regulatory submissions, and life-cycle management of our products, working closely with internal and external stakeholders.

About the Position:

Location:
Istanbul or Ankara

Reports to:
Head of Regulatory, Market Access & Quality Assurance

Key Responsibilities:

  • Prepare and submit Marketing Authorization dossiers of new products in line with local and global regulations
  • Execute regulatory submissions including variations, renewals, labelling updates, etc., in accordance with corporate timelines
  • Manage regulatory life-cycle activities of established products
  • Prepare and follow up GMP inspection submissions for manufacturing sites
  • Prepare and follow up prioritization submissions
  • Support the department head and Regulatory & Market Access Manager throughout product registration processes

Qualifications:

  • Bachelor's degree from 4-year university departments
  • Minimum
    4 years
    of experience in Regulatory Affairs
  • Fluency in English
  • Proficient in MS Office programs
  • Strong team player; open to learning and development
  • Dynamic, well-organized, strong planning and coordination skills
  • Analytical mindset with the ability to create effective and creative solutions

*If this exciting opportunity interests you, send your application via:

**For detailed information regarding personal data, please visit our website:

***Only shortlisted candidates will be contacted after careful review of all applications.



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