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Regulatory Affairs & Compliance Specialist
Johnson & JohnsonRegulatory Affairs & Compliance Specialist supporting execution and improvement of Quality Management System for Johnson & Johnson in Istanbul. Focus on regulatory submissions, compliance, and cross-functional collaboration.
About the role
Key responsibilities & impact- 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
What you’ll need- Bachelor’s degree in Life Sciences/Pharmacy
- Min 5 years in Regulatory Affairs or compliance (pharma preferred)
Benefits
Comp & perks- Inclusive work environment
- Health is everything
- Development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsproduct lifecycle managementcomplianceGxP standardsCAPA trackingregulatory documentationdata managementaudit readinessinspection readinessregulatory changes monitoring
Soft Skills
collaborationcross-functional teamworkcommunication