Regulatory Affairs & Compliance Specialist

Jobtailor; Fatih; On-site; TRY 420,000 - 540,000; Full time

Job summary

Jobtailor is seeking an experienced Regulatory Affairs professional in Turkey to manage submissions, ensure GxP compliance, and support lifecycle processes. The role involves cross-functional collaboration to maintain inspection-ready records and respond to Health Authority inquiries.

Candidates should have a life sciences or pharmacy background with at least five years in regulatory affairs, preferably in pharma, and be familiar with CAPA tracking, data management, and regulatory changes

Qualifications

• Bachelor’s degree in Life Sciences/Pharmacy is required.
• Minimum 5 years in Regulatory Affairs or compliance, pharma preferred.

Responsibilities

• Execute regulatory submissions (registrations, variations, renewals) and support product lifecycle management.
• Ensure compliance with local regulations, GxP standards, and company SOPs; maintain inspection-ready documentation.
• Support audit and inspection readiness, including responses to Health Authority queries and CAPA tracking.
• Maintain regulatory documentation and manage data in regulatory and quality systems.
• Monitor regulatory changes and support implementation across the portfolio.
• Collaborate cross-functionally (Medical, Safety, Quality, Supply Chain) to ensure compliance and supply continuity.

Skills

Regulatory submissions

Product lifecycle management

Compliance

GxP standards

CAPA tracking

Regulatory documentation

Data management

Audit readiness

Inspection readiness

Regulatory changes monitoring

Education

Bachelor’s degree in Life Sciences/Pharmacy

Job description

• Execute regulatory submissions (registrations, variations, renewals) and support product lifecycle management
• Ensure compliance with local regulations, GxP standards, and company SOPs; maintain inspection-ready documentation
• Support audit and inspection readiness, including responses to Health Authority queries and CAPA tracking
• Maintain regulatory documentation and manage data in regulatory and quality systems
• Monitor regulatory changes and support implementation across the portfolio
• Collaborate cross-functionally (Medical, Safety, Quality, Supply Chain) to ensure compliance and supply continuity

Requirements

• Bachelor’s degree in Life Sciences/Pharmacy
• Min 5 years in Regulatory Affairs or compliance (pharma preferred)

Hard Skills

• regulatory submissions
• product lifecycle management
• compliance
• GxP standards
• CAPA tracking
• regulatory documentation
• data management
• audit readiness
• inspection readiness
• regulatory changes monitoring

Soft Skills

• collaboration
• cross-functional teamwork
• communication