Title:  Manager, Regulatory & Public Affairs

Job Specific Accountabilities

• Manages regulatory plans for the submission of new products and maintenance activities for existing products to meet regulatory plans.
• Coordinates all regulatory activates for submissions throughout the regulatory life cycle to ensure proper execution of submissions.
• Reviews submission documentation including correspondences, dossier content and labelling materials to ensure that submissions are of high quality that complies with standards and regulations.
• Maintains awareness of applicable regulations and guidance to keep project teams informed about the new information, along with its possible impact to the projects, as appropriate.
• Participates in communications with health agencies and regulatory authorities to discuss relevant issues and ensure smooth submissions and approvals processes.
• Reviews and provides regulatory input on various types of agreements to make sure they comply with regulatory standards.
• Develops regulatory due diligence reports to evaluate potential products opportunities received from licensors from a regulatory point of view and make appropriate recommendations to colleagues in Business Development department accordingly.
• Identifies potential regulatory risks as part of due diligence activities and propose mitigation plans and alternative regulatory scenarios to support the introduction of new product opportunities from licensors.
• Leads communications with licensors in order to carry out due diligence activities effectively.

Required Criteria:

• Years of Experience: 10  to 15 Years over all,  minimum 7 years in managerial role.
• Qualifications: Bachelor’s degree in pharmacy is a must, master’s in pharmacy, or Business is a plus.
• Area of work: Responsible of Iraq- Base Baghdad