Job Description
Job Description:
Regulatory and Quality Manager
Location: Istanbul, Turkey
Department: Regulatory Affairs & Quality Assurance
About the Role
We are looking for a Regulatory and Quality Manager to ensure end-to-end regulatory compliance across the product lifecycle, while acting as a key interface between regulatory requirements and business operations. This role requires a licensed pharmacist with strong knowledge of Regulatory and Quality frameworks and the ability to work across multiple functional areas including quality, supply chain, and commercial operations.
Key Responsibilities
Regulatory Affairs & Product Lifecycle
- Lead regulatory planning in alignment with departmental priorities
- Manage new product registrations, variations, renewals, and lifecycle maintenance of all marketed products
- Ensure full compliance of product licenses, certifications, and regulatory filings in accordance with local regulations
- Maintain accurate and timely regulatory data within global systems
Health Authority & External Relations
- Manage regulatory inspections and ensure continuous inspection readiness
- Maintain strong professional relationships with relevant authorities and external stakeholders
Compliance & Cross-Functional Operations
- Monitor regulatory changes and assess business impact across functions
- Ensure compliance with local requirements in areas including product quality, distribution, and pricing governance
- Support GDP-compliant processes related to product handling and supply chain interfaces
- Provide regulatory input for pricing, reimbursement submissions, tenders, and market access documentation
Quality & Business Support
- Collaborate with Quality and Supply Chain teams to ensure compliance across product flow and documentation processes
- Support warehouse and distribution compliance requirements in alignment with regulatory standards
- Review promotional and non-promotional materials in accordance with local and global regulations
Qualifications
· University degree in Pharmacy (mandatory)
· Licensed Responsible Pharmacist eligibility in accordance with local regulations
· Minimum 10 years of experience in Regulatory Affairs and Quality within the pharmaceutical industry
· Strong understanding of product lifecycle management and regulatory compliance
· Exposure to quality systems, supply chain, or pricing frameworks is a strong advantage
· Ability to work cross-functionally and manage multiple priorities
· Strong communication skills in English