Manager, Regulatory & Public Affairs

About the role

The Manager, Regulatory & Public Affairs leads the planning and execution of regulatory activities for new product submissions and the maintenance of existing products. Based in Baghdad, the role ensures compliance with local and international regulations while supporting business development initiatives.

Key responsibilities

• Develop and manage regulatory plans for new product submissions and ongoing maintenance activities.
• Coordinate all regulatory activities throughout the product life‑cycle to ensure timely and high‑quality submissions.
• Review submission dossiers, correspondence, labeling, and other documentation for regulatory compliance.
• Monitor changes in regulations and guidance, informing project teams of potential impacts.
• Communicate with health agencies and regulatory authorities to facilitate smooth approval processes.
• Provide regulatory input on agreements to ensure they meet regulatory standards.
• Prepare regulatory due‑diligence reports on potential product opportunities from licensors.
• Identify regulatory risks, propose mitigation plans, and explore alternative regulatory scenarios.
• Lead liaison with licensors to conduct effective due‑diligence activities.

Required profile

• 10‑15 years of overall experience, including at least 7 years in a managerial role.
• Bachelor’s degree in Pharmacy (mandatory); Master’s degree in Pharmacy or Business is a plus.
• Proven experience managing regulatory submissions and interacting with health authorities.
• Strong understanding of regulatory frameworks applicable to pharmaceutical products.

Required skills