About The Role

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