Regulatory and Quality Manager

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