Regulatory Country Strategist – Manpower Middle East LLC
Our client, a multinational Pharmaceutical company, is currently seeking to recruit a Regulatory Country Strategist . You will be reporting directly to the Senior Country StrategistThis is a contract staffing role under Manpower for a period of 12 monthsOrganizational RelationshipClose collaboration with WSR-EM above country and PCO staffPartners with relevant functional teams, including GCMC, Commercial, Submission, labeling, Business and Development, PGM, and WRD (regional and global, where needed).Position PurposeTo manage projects and product-related registration strategies in the assigned countries.Single point of contact for WSR-EM and PCO team on regional issuesTo ensure that regulatory documentation meet relevant regulatory requirements. To apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorisation dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.To ensure business continuity between headquarter Product Strategists and Regulatory PCO staff.To build local relationships and ensure communicationclarity of regulatory timelines and strategyPrimary Responsibilities Resources Managed Supervise Contractors FTE for assigned Projects . RegulatoryApply regulatory expertise for assigned countries to enable preparation of high quality documentation and assure compliance with departmental procedures.Provide input to the WSR-EM regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply)and alignment is achieved between regulatory activities and relevant country businesscommercial plans. Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.Provide input to the localregional Company’s commercial strategic planning process as appropriate.Co-ordinate with Product Strategist the receipt, distribution and response to regulatory queries from target countries, in line with product role in ISR, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.Manage customization and dispatch dossiers to PCOs.Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that WSR-EM is aware of regulatory requirements (e.g., department presentations and RRDB) and assist WSR EM Policy with assessing the regulatory environment and identifying relevant trends.Regularly follow up with PCOs on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.Project ManagementOversee andor facilitate training of Hub activity, including improvements to WSR EM departmental processes and procedures, RRS curriculum, WSR systems and databases, and applicable Company’s policies and procedures.Ensure product strategies, submission and approval time lines, and country registration requirementsguidelines are accurately captured and current in applicable systemsregulatory databases.Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.Participate andor lead cross-functional project teams, to address business needs in line with WSR EM business units, Medical Departments, and County business objectives.Represent their countries at relevant regulatory and project teams, or interdivisional meetings, as appropriateEnsure that comprehensive records of communications, country requirements and regulatory status, are maintained.To regularly follow up progress on regulatory submissions with PCO countries.Contributes to the development of filing and approval goals for the region. EApply for this job.