وظائق شئون قانونية

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Job Description Summary</b></p><br><br>Head of Medical Affairs<br>Location : Cairo<br>#LI-Hybrid<br>We are looking for an experienced Head of Medical Affairs to lead the development and execution of high-impact medical strategies across key disease areas and brands. In this role, you will shape medical affairs plans, drive evidence generation, support launch readiness, and partner with internal and external stakeholders to improve patient outcomes and deliver meaningful value to healthcare systems.<br>This is an opportunity to lead medical strategy for impactful therapies, collaborate with talented teams across markets, and help bring innovative medicines to patients who need them.<br><p><b>Job Description</b></p><br><br><p><b>Major accountabilities: </b></p><br><br><ul><li>Develop and execute high-quality medical strategies for assigned disease areas and brands across their lifecycle.</li><li>Design and implement innovative medical affairs plans that address medical needs, including real-world evidence generation, health economics and outcomes research, digital solutions, medical education, and scientific communications.</li><li>Serve as a trusted disease area medical expert for cross-functional internal teams and external stakeholders, including healthcare professionals and patient advocacy groups.</li><li>Partner with Medical Leads to shape medical affairs strategies, publication plans, educational initiatives, and external scientific engagement activities.</li><li>Build medical capabilities by developing disease area and product-specific training content for field medical teams.</li><li>Provide medical and scientific input into key brand and program documents, including integrated disease area plans, medical information materials, and safety-related documents.</li></ul><br><p><b>Requirements</b></p><br><br><ul><li>MD, PhD, MBBS, or equivalent advanced scientific or medical qualification preferred.</li><li>10+ years of relevant experience in the healthcare or life sciences industry, working with high-performing regional and local medical teams.</li><li>Proven track record of delivering successful medical strategies and supporting innovative medicine launches.</li><li>Strong ability to analyze clinical trial data and translate scientific insights into clear, credible business and medical discussions.</li><li>Deep understanding of clinical practice, evolving treatment landscapes, external industry bodies, and key healthcare system stakeholders.</li><li>Demonstrated people leadership skills, with the ability to collaborate across functions and influence senior stakeholders.</li><li>Fluent in English and Arabic, with strong written and verbal communication skills.</li></ul><br><p><b>Commitment to Diversity and Inclusion:</b></p><br><br><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.</p><br><br><br><p><i><span>Novartis is a proud member of the</span></i><i><span>&nbsp;ILO Global Business and Disability Network</span></i><i><span>&nbsp;and the&nbsp;</span></i><i><span>Valuable 500</span></i><i><span>, promoting the inclusion of people with disabilities in workplaces around the world. We also collaborate with international partners, such as&nbsp;</span></i><i><span>Disability:IN</span></i><i><span>,&nbsp;</span></i><i><span>Purple Space</span></i><i><span>, and&nbsp;</span></i><i><span>Business Disability Forum</span></i><i><span>&nbsp;to identify and develop best practice solutions to enable people with disabilities to participate as equal members of our organization.</span></i></p><br><br><br><br><p><b>Skills Desired</b></p><br><br>Agility (Inactive), Cross-Functional Collaboration, Drug Development, Healthcare Sector Understanding (Inactive), Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation (Inactive), Medical Affairs, Medical Education (Inactive), Patient Care, People Management, Priority Disease Areas Expertise (Inactive), Product Launches, Product Strategies, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies, Results-Oriented, Stakeholder Engagement, Stakeholder Management, Statistical Analysis, Strategic Alliances<br> </div>

Responsibilities:<br>Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines including upload of regulatory relevant information to the UTS database. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to complex problems in which data analysis requires an evaluation of intangible variables. Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new Cosmetics / Personal Care Products. Global Regulatory impact assessments for all changes at the manufacturing sites and ensuring submission of relevant changes if needed Review (in view of compliance with regulatory requirements) and approve text drafts and artworks of labels packaging and instructions for use for assigned products. Supporting the Regulatory Affairs part of audits<br>Requirements: <br>BSc degree (or equivalent) preferably in a related Science field (Chemistry, Biology) is strongly preferred. From 1 to 5 years of experience in Cosmetics and Personal Care. Direct work experience in Regulatory / Registration field. Demonstrated communication skills, must be able to summarize and articulate technicalinformation to diverse audiences both verbally and in writing. Problem solving skills with the ability to bring projects to a conclusion. Excellent communication in English.

Regulatory Affairs Specialist – Egypt<br>Kelly Science, Engineering, Technology & Telecom | Egypt (Remote) Employment Type: Full-Time, 12-Month Fixed-Term Contract Location: Remote, Egypt Start Date: Immediate Contract: Initial 12-month FTC, with potential for extension<br>About the Opportunity:<br>Kelly Science, Engineering, Technology & Telecom is recruiting for an exciting opportunity with a leading global medical technology organisation. The client develops innovative healthcare products and solutions that support patients, healthcare professionals and healthcare systems worldwide.<br>With an established international presence and a broad portfolio of medical devices, the organisation is committed to advancing healthcare, improving patient outcomes and maintaining the highest standards of product quality, safety and regulatory compliance.<br>This opportunity is being offered through Kelly's FSP (Functional Service Provider) model, where you will be employed by Kelly and assigned to the client's regulatory team.<br>We are looking for an experienced Regulatory Affairs professional based in Egypt who can act as the primary local regulatory representative, supporting the client's medical device portfolio and working closely with the local distributor.<br>This is a hands-on regulatory role, offering the opportunity to take ownership of local regulatory activities, provide expert guidance and work directly with an international medical technology organisation.<br>Key Responsibilities Act as the primary local Regulatory Affairs contact and representative for the client in Egypt. Work closely with the local distributor to support regulatory activities for the client's medical device portfolio. Support and coordinate regulatory submissions to the Egyptian Drug Authority (EDA). Prepare, review and organise regulatory documentation, submission packages and supporting materials. Provide hands-on regulatory expertise and guidance to the distributor, helping them understand and meet local medical device requirements. Maintain awareness of the Egyptian medical device regulatory landscape, including relevant rules, requirements and procedural changes. Support regulatory queries, documentation requests and follow-up activities with the distributor and internal client stakeholders. Coordinate with internal Regulatory Affairs and cross-functional teams to ensure local requirements are understood and addressed. Maintain regulatory records, trackers and internal systems, including MDRiM and other relevant regulatory administration activities. Ensure regulatory activities are appropriately documented, tracked and escalated where required. Contribute to the ongoing maintenance of regulatory compliance and effective communication between the client, distributor and relevant stakeholders.<br>Candidate Requirements:<br>Essential Experience Previous experience in Regulatory Affairs within the medical device industry. Hands-on experience supporting medical device regulatory activities in Egypt. Practical knowledge of the Egyptian Drug Authority (EDA) and local regulatory requirements for medical devices. Experience preparing, reviewing or coordinating medical device regulatory submissions and documentation. Ability to provide regulatory guidance and work directly with distributors or local regulatory stakeholders. Strong understanding of regulatory processes, requirements and compliance expectations within the Egyptian medical device market. Strong organisational skills, attention to detail and the ability to manage multiple regulatory activities. Fluent or professional-level English, with strong written and verbal communication skills. Desirable Experience Experience acting as a local regulatory representative or primary regulatory contact. Experience working with a multinational medical device company or through an FSP environment. Familiarity with internal regulatory information systems, including MDRiM. Experience managing distributor relationships and supporting regulatory submissions from document preparation through to follow-up. Experience across multiple medical device product categories or regulatory pathways in Egypt.<br>What Kelly Offers:<br>Through Kelly's FSP model, you will be employed by Kelly and assigned to a global medical technology client for an initial 12-month fixed-term contract, with potential for extension depending on project requirements and performance.<br>This remote-based opportunity offers the chance to become a dedicated regulatory specialist supporting the client's local market while collaborating with international colleagues and distributor partners.<br>The role provides valuable exposure to local regulatory strategy, distributor engagement and regulatory operations within a global medical device environment.<br>Apply Now:<br>Candidates with relevant medical device Regulatory Affairs experience in Egypt, particularly those with EDA experience, are encouraged to apply.<br>This is an immediate requirement, and the client is looking to progress suitable candidates quickly. Employment: Kelly Science, Engineering, Technology & Telecom, under an FSP model.<br>Contract: 12-month FTC, with potential for extension. Location: Remote, Egypt. Start: As soon as possible. Client: Global medical technology organisation, name confidential at this stage.

“Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.”<br>Responsibilities:<br>Coordinate the preparation and submission of regulatory documents for Parkville’s products, ensuring compliance with relevant standards. Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly. Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases. Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs). Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication. Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible. Develop and review product leaflets (SPC & PIL) and submit them to the appropriate regulatory authorities for approval. Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies. of Health / CAPA.<br>Requirements:Education:Bachelor’s degree from reputable university Degree in Pharmacy, Veterinary Medicine, Science is an advantage.<br>Experience:Previous experience in pharmaceuticals industry from 3-4 years in the same position, responsibilities.

“Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.”<br>Responsibilities:<br>Coordinate the preparation and submission of regulatory documents for Parkville’s products, ensuring compliance with relevant standards. Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly. Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases. Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs). Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication. Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible. Develop and review product leaflets (SPC & PIL) and submit them to the appropriate regulatory authorities for approval. Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies. of Health / CAPA.<br>Requirements:Education:Bachelor’s degree from reputable university Degree in Pharmacy, Veterinary Medicine, Science is an advantage.<br>Experience:Previous experience in pharmaceuticals industry from 3-4 years in the same position, responsibilities.

Company Description Hefny Pharma Group (HPG) is a national pharmaceutical manufacturer and seller committed to delivering high-quality medicines to patients and healthcare providers. The group focuses on integrating innovation, strict quality standards, and broad accessibility to meet diverse healthcare needs. HPG operates with a strong emphasis on compliant production processes and product reliability. The company’s mission is to advance healthcare outcomes while maintaining affordability and trust in its products. Role Description The Regulatory Affairs Specialist is a full-time, on-site role based in Nasr City, responsible for managing regulatory activities across the product lifecycle. In this position, the specialist prepares, reviews, and maintains regulatory documentation and submissions for new and existing pharmaceutical products. Daily responsibilities include monitoring changes in regulatory requirements, ensuring ongoing regulatory compliance, and coordinating with internal teams such as Quality, R&D, and Production to gather necessary data. The role involves responding to regulatory authority queries, supporting product registration and variation processes, and keeping accurate records and tracking systems updated. The specialist also contributes to internal training on regulatory policies and supports continuous improvement in regulatory processes. Qualifications Bachelor's degree in Science or Pharmacy· More than 2 years’ experience in human pharmaceuticals registration & Cosmetics· Experience with regulatory submissions and interactions with health authorities· Ability to work effectively in a team· Excellent communication and analytical skills.

Job Summary:The Trading Affairs Manager is responsible for managing and controlling the commercial cycle of electricity and water utility services, including billing, tariff management, customer accounts, collection monitoring, Electricity and Water suppliers invoice validation, energy balance, commercial losses, and performance reporting. The role ensures accurate consumption-to-billing conversion, proper revenue capture, effective commercial controls, and reliable reporting across the company’s projects.<br>Key Responsibilities Manage the monthly billing cycle for prepaid and postpaid electricity and water customers, ensuring accuracy and timely completion. Review meter readings and consumption data and investigate missing readings, abnormal consumption, unbilled customers, and billing discrepancies. Manage and validate tariffs, consumption brackets, service fees, and other applicable charges across different projects and customer categories. Monitor customer accounts, billing adjustments, outstanding balances, and commercial disputes. Monitor collection performance, collection ratios, outstanding receivables, and aging and highlight collection risks to management. Review and validate electricity and water supplier invoices, including meter readings, consumption quantities, tariffs, and invoice values before payment processing. Prepare and monitor energy/water balance, comparing purchased versus sold quantities and analyzing losses in k Wh/m³, percentage, and financial value. Identify potential revenue leakage and commercial losses and coordinate corrective actions with Metering, Inspection & Monitoring, Operations, and other concerned teams. Perform reconciliation between prepaid metering systems, billing systems, ERP, and financial records. Monitor contractual revenues, service charges, revenue-sharing mechanisms, and other commercial contractual obligations. Prepare periodic management reports covering billing, revenue, collections, purchased utilities, losses, outstanding receivables, and overall project commercial performance. Lead and develop the Trading Affairs team and establish effective workflows, controls, and procedures.<br>Qualifications:Bachelor's degree in Engineering, Commerce, Accounting, Business Administration, or related field.7–10 years of relevant experience, preferably within electricity/water utilities, distribution, smart metering, billing, or similar businesses. Minimum 3 years in a supervisory or managerial position. Strong experience in utility billing, metering/consumption data, energy balance, revenue assurance, and commercial reporting. Experience with prepaid and postpaid billing environments is preferred. Strong knowledge of ERP/billing systems and advanced Microsoft Excel. Power BI and smart metering/AMI experience are considered an advantage.<br>If interested, please send your updated resume in a PDF format to: jobs@madkour.com.eg mentioning the job title in the e-mail subject.