Regulatory and Quality Manager

About the role

We are seeking a Regulatory and Quality Manager to lead end‑to‑end regulatory compliance across the product lifecycle. The role bridges regulatory requirements with business operations and requires a licensed pharmacist with deep knowledge of regulatory and quality frameworks.

Key responsibilities

• Lead regulatory planning aligned with departmental priorities and manage new product registrations, variations, renewals, and lifecycle maintenance.
• Ensure full compliance of product licences, certifications and regulatory filings with local regulations and maintain accurate data in global systems.
• Manage regulatory inspections, maintain inspection readiness and foster strong relationships with health authorities and external stakeholders.
• Monitor regulatory changes, assess business impact and support cross‑functional compliance in quality, distribution, pricing and supply‑chain processes.
• Provide regulatory input for pricing, reimbursement, tenders and market‑access documentation.
• Collaborate with Quality and Supply Chain teams to guarantee compliance of product flow, documentation and warehouse/distribution activities.
• Review promotional and non‑promotional materials for adherence to local and global regulations.

Required profile

• University degree in Pharmacy (mandatory) and a licensed Responsible Pharmacist status according to 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.
• Experience with quality systems, supply‑chain processes or pricing frameworks is a strong advantage.
• Ability to work cross‑functionally and manage multiple priorities.
• Excellent communication skills in English.

Required skills

• Regulatory Affairs
• Quality Assurance
• Product Lifecycle Management
• Good Distribution Practice (GDP) compliance