Islam Ahmed Hamed

Project Management Officer (PMO Manager) Hikma PharmaFull Time

• Job Details:- Coordination and completion of projects on time within budget and within scope. - Oversee all aspects of projects, set deadlines, assign responsibilities and monitor and summarize progress of project. - Prepare reports for upper management regarding status of project. - Participates in the development and implementation of R&D PMO policies, processes and procedures to ensure all relevant procedural/legislative requirements are fulfilled. - Prepares the development of R&D PMO budget and monitors financial performance versus the budget to ensure alignment. - Manages the effective achievement of objectives by setting individual targets, developing and motivating staff to maximize subordinate performance. - Supervises the activities and work of subordinates to ensure that all work within a specific area is carried out in an efficient manner and in compliance with the set policies, processes and procedures. - Work with the various functions (API, R&D, RA, IP, Marketing) to develop timelines for each product - Work closely and align the functions on priorities and manage the projects – hold project team meetings, resolve conflicts, escalate issues as needed to accelerate the development and registration timeline of new products - Manages the day-to-day operations o PMO by providing guidance, encouraging teamwork and facilitating related professional work processes to achieve high performance standards.

Regulatory affairs managerFull Time

• Job Details:- Reviews product labeling/advertising to ensure compliance with HA regulations - To assist with marketing and generating new business - Provide continuing regulatory education and dissemination of regulatory information to the development, marketing and clinical groups - Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects - Independently map out filing and regulatory strategy - Actively contribute to the development and functioning of the crisis/issue management program - Manage and execute preapproval compliance activities - Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes - Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management - Provide regulatory input for product recalls and recall communications - Provide regulatory input to product lifecycle planning - Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval - Raising of internal and external awareness of regulatory developments - Determining effective regulatory pathways for a variety of products types