Regulatory Affairs Manager

6 days ago

Istanbul, Istanbul, Turkey TalentIST People Solutions Full time ₺50,000 - ₺100,000 per year

As part of our consultancy partnership with
THEA Pharma
, we are searching for an experienced
Regulatory Affairs Manager
who will play a key role in ensuring regulatory excellence, compliance, and smooth market access operations in Turkey.

Responsibilities

Near & Long-Term Goals:

  • Lead all regulatory applications related to new product licensing and license maintenance/improvement for existing products, in alignment with local regulations and company procedures.
  • Manage regulatory processes according to strategic business decisions on product licensing in Turkey.
  • Coordinate and update SOPs, reports, presentations, launch tables, and regulatory databases.
  • Monitor regulatory changes and ensure full compliance.
  • Support the Responsible Pharmacist and Qualified Scientific Person in quality, market access, business compliance, and pharmacovigilance.
  • Oversee GMP-related activities: organizing audits, accompanying auditors, and ensuring timely issuance of GMP certificates.
  • Handle license and GMP renewals, Type I/II variations, artwork changes, SmPC-PIL updates, deficiency responses, and approval processes.
  • Manage business compliance duties.
  • Follow up on quality-related issues stemming from pharmacovigilance reports.
  • Support cost-effectiveness studies and budget impact models for new product launches.

Requirements

  • Bachelor's degree in Pharmacy
  • Advanced level of written and spoken English
  • Proficiency in MS Office applications
  • (For male candidates) Completed military service
  • 7–8 + years of experience in Regulatory Affairs

Skills

  • Strong organizational and planning abilities
  • Effective communication skills
  • Problem-solving capability
  • Technical expertise in regulatory processes
  • Project management skills
  • High attention to detail
  • Commitment to ongoing learning about industry regulations
  • Strong time management
  • Willingness to travel

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