Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectives.Build priority Plans to identify resource gaps, make priority calls, propose solutions, including third parties.Management of assigned regulatory projects (planning and managing regulatory activities on both new and in-line products in accordance with the regulations and company policies.Develop registration strategies and lead the registration process for all products (medicine, health products, food supplements, medical devices, cosmetics…etc) in scope in the assigned countries.Ensure regulatory compliance of registered products, promotional material, and related commercial initiatives .Manage Labeling/Artwork differences in scope in the assigned countries including SPC, PIL, inter and outer artwork. Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements and internal policies and procedures including but not limited to advertising, packaging communications, and import procedures.Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or insights that will impact the business.Ensure Regulatory budget is delivered. Manage the expenses as per budget planningEnsures up to date data reportingQPPV backup person

Effective planning and implementation of annual registration plan.Participation with management team in evaluating new introductions from regulatory point of view.Setting midyear & annual objectives.Securing Marketing authorizations & approvals through continuous follow up & direct communications wit decision makers & key opinion leaders in MOH.Successful handling of negotiations leading to suitable solutions with MOH compatible with company policy.Fast professional response to regulatory authorities’ queries.Preparing, submission and following all company fileincluding new & Re-Reg files in a timely manner.Effective cooperation dealing with supply chain department to ensure the safe and compliance supply.Hard worker with strong capability follow up all the different activities.Ensuring Compliance of scientific materials with regulatory requirements.Building-up healthy professional relationship with regulatory authority/bodies.keeping up-to-date with changes in regulatory guidelines.Revising all batch records from regulatory point of view.Generate DRA SOPs.Transversal cooperation with other pharmaceutical companies (Toll –Partnership)Responsible for artwork approvals cycle (Internally & Externally).Responsible for Export department establishing.Develop and maintain good working relationships withother FPI departments.Deliver team capability, coach, and develop team members, own career development & compensation, determine priorities, set the work, and ensures technical rigor for team members.

Prepare & submit drug registration files in a timely manner. •Follow up of the files with MOH officials to achieve a favourable outcome. •Get the registration & re-registration approvals in due time. •Re-registration of the old products (registered since 10 years) – In due time & with minimum supervision. •Develop and maintain good working relationships with other departments •Submission & approval of production transfer in due dates. •Submission & approval of variations in due dates. •Package insert update and new indications approvals in due dates. •Post registration variations submission & approval in due dates according to marketing plans •Provide adequate training and guidance to all junior regulatory associates as requested by Drug Regulatory Affairs Head. •Attending/participating/contributing in local authority’s annual & regular meetings/conferences. •Utilizing public relations motivation tools to strengthen relationship with MOH officials. *Act as a back-up person for pharmacovigilance qualified person (QPPV).