medical representative

planning specialist

associate | regulatory | qrs | egypt Jobs in Cairo

associate | regulatory | qrs | egypt

clinical data specialist

commercial projects senior officer Jobs in Cairo

commercial projects senior officer

senior regulatory affairs specialist

PHARAONIA Pharmaceuticals

<div>
 
 
 Job Purpose:
 
 
 
 
 
 <ul>
 <li>
 To prepare, compile, and submit high-quality regulatory documentation to health authorities to gain and maintain marketing authorizations for the company's products. This role ensures that all activities are performed in strict compliance with the applicable regulations for the assigned domain.
 </li>
 </ul>
 
 
 
 
 
 Key Accountabilities and Decision Ownership:
 
 
 
 
 
 <ul>
 <li>
 Compile, format, and review scientific and technical data to prepare regulatory dossiers (e.g., CTD modules) for new products, variations, and renewals.
 </li>
 <li>
 Prepare and manage documentation for international product registrations, including legal documents and responses to queries from foreign agents/authorities.
 </li>
 <li>
 Maintain detailed and organized records of all regulatory submissions, correspondence, and approvals.
 </li>
 <li>
 Review product labeling, leaflets, and promotional materials for regulatory compliance.
 </li>
 <li>
 Stay updated with current regulations and guidance documents relevant to the assigned area.
 </li>
 <li>
 
 (For Senior Specialist)
 
 Mentor junior specialists, handle more complex submissions, and contribute to regulatory strategy discussions.
 </li>
 </ul>
 
 
 
 
 
 Technical &amp; professional qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy or a related Life Science is required.
 </li>
 <li>
 1-3 years of experience in regulatory affairs or a related field (e.g., QA, R&amp;D).
 </li>
 </ul>
 
 
 
 
 
 Skills:
 
 
 
 
 
 <ul>
 <li>
 Technical Writing
 </li>
 <li>
 Organizational Skills
 </li>
 <li>
 Microsoft Office (Word, Excel)
 </li>
 <li>
 Problem-Solving
 </li>
 <li>
 Communication
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Specialist (Export)

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 &nbsp;
 
 
 
 Job Summary:
 
 
 
 We are seeking a passionate and talented
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 <ul>
 <li>
 Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmaceutical Sciences
 </li>
 <li>
 +2 years of experience in Regulatory Affairs in international Markets.
 </li>
 <li>
 Fluent in English (written &amp; verbal) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Specialist

Amgen

<div>
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 <ul>
 <li>
 If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
 
 
 </li>
 </ul>
 Job purpose:
 
 
 <ul>
 <li>
 As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
 
 
 </li>
 </ul>
 Job Responsibilities:
 
 
 <ul>
 <li>
 Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
 </li>
 <li>
 Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate
 </li>
 <li>
 Participate in local regulatory process improvements initiatives
 </li>
 <li>
 Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
 </li>
 <li>
 Ensure delivery of right first time label source text for artwork creation
 </li>
 <li>
 Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
 </li>
 <li>
 Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
 </li>
 <li>
 Access the translation agency systems to request the label translation and track the job readiness and timelines.
 </li>
 <li>
 Perform regional prescribing information translation review: 100% review of both content and format
 </li>
 <li>
 Perform the role of source text owner/approver and artwork reviewer/approver in the system
 </li>
 <li>
 Trigger the existing label revision when alerted by global RA team.
 </li>
 <li>
 Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
 </li>
 <li>
 Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
 
 </li>
 </ul>
 Qualifications:
 
 
 <ul>
 <li>
 Experience +2 years in Regulatory Affairs
 </li>
 <li>
 Current/ previous experience in working as part of an MNC employer
 </li>
 <li>
 Pharmacist, biologist, chemist-medical background
 </li>
 <li>
 Fluent in English and Arabic for translation review purpose ( French is a huge plus)
 </li>
 <li>
 A minimum knowledge of Middle East Africa regulatory requirements
 </li>
 <li>
 Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
 </li>
 <li>
 Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.
 
 
 </li>
 </ul>
 What You Can Expect Of Us
 
 
 As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 <ul>
 <li>
 Vast opportunities to learn and move up and across our global organization
 </li>
 <li>
 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
 </li>
 <li>
 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
 </li>
 </ul>
 Apply now for a career that defies imagination
 
 
 In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
 
 
 careers.amgen.com
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
 
 
 We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
</div>

MEA Regulatory Affairs Senior Associate

Fawry MSME Finance

<div>
 
 <ul>
 <li>
 Support the implementation and monitoring of compliance programs, ensuring adherence to internal policies, regulations, and legal standards.
 
 </li>
 <li>
 Conduct regular compliance audits, report findings, and provide actionable recommendations to management.
 
 </li>
 <li>
 Draft, review, and update compliance policies and procedures to ensure alignment with regulatory requirements, internal practices, and industry standards.
 
 </li>
 <li>
 Stay up to date with FRA regulations related to microfinance and advise management on any regulatory changes.
 
 </li>
 <li>
 Identify compliance risks across the organization and propose effective mitigation plans, while collaborating with different teams to implement solutions.
 
 </li>
 <li>
 Handle FRA-related complaints and compliance inquiries, and support investigations of violations, including fraud cases, ensuring proper documentation and resolution.
 
 </li>
 <li>
 Lead compliance training and awareness initiatives, and support the preparation of periodic compliance reports for senior management.
 
 </li>
 </ul>
 
 
 
 
 
 
 Requirements
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Law, Business Administration, Commerce, or a related field.
 
 </li>
 <li>
 3&ndash;5 years of experience in Compliance, AML, or Legal roles, preferably within the Financial Services sector.
 
 </li>
 <li>
 Knowledge of FRA&rsquo;s regulatory requirements.
 
 </li>
 <li>
 Strong understanding of regulatory frameworks and compliance requirements.
 
 </li>
 <li>
 Experience in dealing with the Financial Regulatory Authority (FRA) is preferred.
 
 </li>
 <li>
 Ability to work independently and as part of a team while meeting deadlines.
 
 </li>
 <li>
 Proficiency in both written and spoken Arabic is required.
 
 </li>
 <li>
 Strong ability to manage multiple priorities and compliance-related projects efficiently.
 
 </li>
 <li>
 High attention to detail to ensure adherence to policies, procedures, and regulations.
 
 </li>
 <li>
 Strong organizational and problem-solving skills.
 
 </li>
 <li>
 Understanding of compliance, AML practices, and internal control frameworks.
 
 </li>
 </ul>
</div>

Senior Compliance Specialist

CTI Clinical Trial and Consulting Services

<div>
 
 About The Job
 
 
 
 Manage essential Regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist and advise the study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.
 
 
 
 What You'll Do
 
 
 
 <ul>
 <li>
 Assist/advise project teams on all regulatory requirements for clinical studies
 </li>
 <li>
 Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
 </li>
 <li>
 Review and adapt study specific documents according each country and site requirements
 </li>
 <li>
 Perform IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirements
 </li>
 <li>
 Receive and process study documentation from sites, check content and quality as well as completeness
 </li>
 <li>
 Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
 </li>
 <li>
 Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
 </li>
 <li>
 Assist with and adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level
 </li>
 <li>
 Assist in preparation, quality check and filing of site adapted ICF according to local requirements
 </li>
 <li>
 Prepare and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
 </li>
 <li>
 Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
 </li>
 <li>
 Respond to Deficiency Letters from IRB/EC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
 </li>
 <li>
 Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
 </li>
 <li>
 Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
 </li>
 <li>
 Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
 </li>
 <li>
 Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
 </li>
 <li>
 Assist with preparation for Sponsor or Agency audits and inspections
 </li>
 <li>
 Assist with QC and QA of various study related Regulatory documents and reports.
 </li>
 <li>
 Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
 </li>
 <li>
 Attend internal and external study meetings and regulatory status reports for each site and country during study meetings Sites budgets and Sites contracts management, depending from Countries/Regions
 
 
 </li>
 </ul>
 
 Required Education And Experience
 
 
 
 <ul>
 <li>
 Associate&rsquo;s or Bachelor&rsquo;s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
 </li>
 <li>
 A minimum of 1 - 2 years of relevant pharmaceutical, site, or CRO Regulatory experience
 
 
 </li>
 </ul>
 
 COMPETENCIES
 
 
 
 <ul>
 <li>
 Ongoing willingness to learn
 </li>
 <li>
 Detail oriented
 </li>
 <li>
 Ability to collaborate well in a team environment
 </li>
 <li>
 Ability to maintain confidentiality
 </li>
 <li>
 Proficient in use of computer and software systems
 </li>
 <li>
 Excellent verbal and written communication skills
 </li>
 <li>
 Fluent in oral and written English
 </li>
 <li>
 Ability to provide superior level of customer service
 </li>
 <li>
 Ability to develop, prioritize, organize, and manage multiple tasks
 </li>
 <li>
 Decision making and creative problem-solving skills
 </li>
 <li>
 Working knowledge and understanding of applicable country regulations, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines
 
 
 </li>
 </ul>
 
 Important Note
 
 
 
 In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
 
 @ctifacts.com
 
 email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
 
 
 
 Please Note
 
 
 
 <ul>
 <li>
 We will never communicate with you via Microsoft Teams or text message
 </li>
 <li>
 We will never ask for your bank account information at any point during the recruitment process.
 </li>
 </ul>
</div>

Regulatory Affairs Study Start Up Specialist I

<div>
 
 
 Key Accountabilities and Decision Ownership:
 
 
 
 
 
 
 &bull; Implement the group&rsquo;s export strategy within assigned region(s) to achieve revenue and market share targets.
 
 
 &bull; Manage regional distributors, agents, and partners, including selection, negotiation, and performance monitoring.
 
 
 &bull; Conduct regional market analysis to identify growth opportunities and recommend entry strategies.
 
 
 &bull; Oversee regional export operations, including documentation, logistics, customs clearance, and timely delivery.
 
 
 &bull; Coordinate with Regulatory Affairs for product registration and compliance with local health authorities.
 
 
 &bull; Prepare regional sales forecasts, budgets, and pricing strategies aligned with group objectives.
 
 
 &bull; Monitor regional market conditions, competitor activities, and regulatory changes to adapt plans and mitigate risks.
 
 
 &bull; Represent the company at regional trade fairs, exhibitions, and business meetings.
 
 
 
 
 
 Academic, technical, and professional qualifications:
 
 
 
 
 
 
 &bull; Bachelor&rsquo;s degree in Pharmacy, Life Sciences, International Business, or a related field.
 
 
 An MBA or postgraduate degree in International Business/Export Management is a plus.
 
 
 
 
 
 
 Experience:
 
 
 
 &bull; Minimum 5+ years of experience in a pharmaceutical export position.
 
 
 
 
 
 
 Core Competencies:
 
 
 
 &bull; Result Orientation.
 
 
 &bull; Active Change.
 
 
 &bull; Customer Engagement.
 
 
 &bull; Proactive Cooperation.
 
 
 &bull; Business Acumen
 
 
 &bull; Leadership
 
 
 
 Management Competencies:
 
 
 
 &bull; Managing People and Performance
 
 
 &bull; Strategic Orientation
 
 
 
 Functional Competencies:
 
 
 
 &bull; Decision Making
 
 
 &bull; Knowledge &amp; Selling Skills
 
</div>

Group Export Regional Manager

Magnet

<div>
 
 
 Employer Overview
 
 
 
 A fast-growing international digital marketplace dedicated to transforming the second-hand fashion ecosystem and promoting sustainable, circular commerce. The platform enables individuals to buy and sell pre-loved items through a trusted peer-to-peer model, making fashion more accessible while supporting communities and encouraging environmentally responsible consumption.
 
 
 
 
 
 
 Job Summary
 
 
 
 Senior Operations Specialist (E-commerce) will play a key role in establishing and growing marketplace operations in Egypt and the UAE. This role focuses on building the initial supply ecosystem, developing strategic partnerships, and setting up operational and logistics infrastructure to support successful market entry and long-term scalability.
 
 
 
 
 
 
 Key Responsibilities
 
 
 <ul>
 <li>
 Recruit and onboard the first wave of sellers in Egypt and the UAE through local resellers, thrift communities, and second-hand ecosystems to establish supply-side growth.
 </li>
 <li>
 Act as the primary point of contact for sellers during the launch phase, understanding their needs and building strategies to improve engagement and retention.
 </li>
 <li>
 Identify, evaluate, and negotiate partnerships with last-mile delivery providers in Egypt and the UAE aligned with the company&rsquo;s C2C shipping model.
 </li>
 <li>
 Lead logistics setup in both markets, including partner onboarding, platform integration, COD reconciliation, SLA definition, and performance monitoring.
 </li>
 <li>
 Track logistics performance metrics such as delivery success rate, COD rejection rate, transit time, and shipment cost, driving continuous operational improvements.
 </li>
 <li>
 Support the setup of local legal entities by coordinating with legal advisors and facilitating HQ-led processes.
 </li>
 <li>
 Assist HQ in navigating local regulatory requirements, including consumer protection, data privacy, and e-commerce regulations.
 </li>
 <li>
 Establish relationships with relevant authorities and support compliance initiatives within the market.
 </li>
 <li>
 Contribute to developing localized customer support processes and workflows.
 </li>
 <li>
 Collaborate with the marketing team to analyze the competitive landscape and identify opportunities for market growth.
 </li>
 </ul>
 
 
 
 
 
 Minimum Requirements
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Business, or a related field.
 </li>
 <li>
 6&ndash;8 years of experience in business development, logistics, e-commerce, commercial operations, or marketplace operations.
 </li>
 <li>
 In-depth knowledge of Egypt's last-mile delivery ecosystem; ability to reach key players, understand capabilities, and structure and negotiate partnerships.
 </li>
 <li>
 Comfortable operating at the intersection of strategy and hands-on execution, managing multiple work streams without a local team.
 </li>
 <li>
 Familiarity with legal, regulatory, or compliance processes in Egypt.
 </li>
 <li>
 Strong communication and relationship-building skills.
 </li>
 <li>
 Strategic thinking with a hands-on execution mindset.
 </li>
 <li>
 Problem-solving and negotiation skills.
 </li>
 <li>
 Strong stakeholder management capabilities.
 </li>
 <li>
 Knowledge of last-mile delivery partnerships and logistics operations.
 </li>
 <li>
 Ability to track and analyze operational KPIs and performance metrics.
 </li>
 <li>
 Understanding of regulatory and compliance considerations in e-commerce environments.
 </li>
 <li>
 Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
 </li>
 <li>
 Familiarity with CRM tools, marketplace platforms, or operational tracking systems is a plus.
 </li>
 <li>
 Fluent in English for daily collaboration with the remote, international HQ team.
 </li>
 <li>
 Ability to operate independently and build processes from the ground up.
 </li>
 </ul>
</div>

Senior Operations Specialist (E-commerce)

Explore 412+ Senior regulatory affairs specialist in Cairo this April. Find roles across top companies and apply now to boost your career.