Regulatory Affairs Manager, Türkiye

Bilbao HR

İstanbul, Turkey
On-site
Turkish health authority interactions
Dossier preparation and submission
Lifecycle management activities
The Regulatory Affairs Manager position at Bilbao HR is a key role focused on overseeing regulatory activities in Türkiye, including submissions for marketing authorizations and post-registration variations. The ideal candidate will have extensive experience in regulatory affairs within the Turkish pharmaceutical landscape, as well as strong collaborative and problem-solving skills

Job Summary

  • Support the execution of regulatory activities for the assigned portfolio to ensure submissions and approvals of new marketing authorization applications (MAAs) and post-registration variations within agreed timelines.
  • Lead local regulatory submission activities for new marketing authorization applications, lifecycle management activities, label changes, technical updates, packaging updates, and post-approval variations for assigned products.
  • Monitor and communicate changes in Turkish pharmaceutical legislation, regulatory policies, and packaging guidelines, providing proactive regulatory intelligence to the business.

Matching Summary

Match Score: 85

The Regulatory Affairs Manager position at Bilbao HR is a key role focused on overseeing regulatory activities in Türkiye, including submissions for marketing authorizations and post-registration variations. The ideal candidate will have extensive experience in regulatory affairs within the Turkish pharmaceutical landscape, as well as strong collaborative and problem-solving skills.

Skills & Requirements

Must-have

  • Turkish Health Authority interactions
  • Dossier preparation and submission
  • Lifecycle management activities
  • GMP processes and submissions
  • Labeling and packaging updates
  • Turkish pharmaceutical legislation

Nice-to-have

  • Proactive and solution-oriented mindset
  • Strong cross-functional relationships
  • Resilient and adaptable in evolving environments
  • Culturally aware and collaborative

Key Requirements

  • 5-7 years experience in Regulatory Affairs in Türkiye
  • Health Related sciences background and education
  • Broad knowledge of Türkiye’s pharmaceutical legislation
  • Proven hands-on experience managing GMP submissions
  • Excellent written and verbal communication skills in Turkish and English

Work Rights

Not specified

Tailored Resume

Cover Letter