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POS Enterprise

<div>
 
 
 Job Title:
 
 Regulatory Affairs Specialist
 
 
 
 Company:
 
 POS Enterprise
 
 
 
 Location:
 
 Egypt (with flexibility to travel internationally)
 
 
 
 Job Summary:
 
 
 
 We are seeking an experienced Regulatory Affairs Specialist with over 5 years of experience in medical devices. The ideal candidate will have a strong background in registering products both within Egypt, internationally and the ability to manage regulatory processes efficiently across multiple markets. This role requires excellent knowledge of local and global regulatory requirements, along with a proactive approach to ensuring compliance and timely product approvals.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Manage and oversee regulatory submissions for medical devices in Egypt and international markets.
 </li>
 <li>
 Prepare, review and submit registration dossiers in compliance with local and global regulatory requirements.
 </li>
 <li>
 Liaise with regulatory authorities to ensure timely approvals and address any queries or deficiencies.
 </li>
 <li>
 Maintain and update product registrations, including variations, renewals and post-marketing requirements.
 </li>
 <li>
 Ensure compliance with applicable laws, guidelines and standards.
 </li>
 <li>
 Coordinate with internal departments (quality, production, marketing) to gather necessary documentation.
 </li>
 <li>
 Monitor changes in regulatory regulations and communicate impacts to the business.
 </li>
 <li>
 Support product lifecycle management and regulatory strategy planning.
 </li>
 </ul>
 
 
 
 
 
 Qualifications &amp; Requirements:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy, Medicine, or a related field.
 </li>
 <li>
 Minimum of 5 years of experience in Regulatory Affairs within the medical device industry.
 </li>
 <li>
 Proven experience in registering products in Egypt and other international markets.
 </li>
 <li>
 Strong knowledge of Egyptian Drug Authority (EDA) regulations and international regulatory frameworks.
 </li>
 <li>
 Excellent documentation and dossier preparation skills.
 </li>
 <li>
 Strong communication and organizational skills.
 </li>
 <li>
 Ability to work independently and manage multiple projects simultaneously.
 </li>
 <li>
 Willingness and ability to travel when required.
 </li>
 </ul>
 
 
 
 
 
 Preferred Skills:
 
 
 <ul>
 <li>
 Experience with
 
 medical devices, including CGM (Continuous Glucose Monitoring), is a plus
 
 .
 </li>
 <li>
 Familiarity with CTD/eCTD formats.
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Specialist

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>

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)

Kraft Heinz

<div>
 The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
 </li>
 <li>
 Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
 </li>
 <li>
 Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
 </li>
 <li>
 Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
 </li>
 <li>
 Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
 </li>
 <li>
 Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
 </li>
 <li>
 Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
 </li>
 <li>
 Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
 </li>
 <li>
 Proactively identify and communicate SRA risk in any project or work stream
 </li>
 <li>
 Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
 </li>
 <li>
 Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
 </li>
 <li>
 Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
 </li>
 <li>
 Provide technical and legal labelling Information and support artwork approval process
 </li>
 <li>
 Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
 </li>
 <li>
 Scientific and regulatory affairs representation in all projects driven forums
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
 </li>
 <li>
 5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
 </li>
 <li>
 Experience working with Microsoft programs and system tools related to recipes and artworks
 </li>
 <li>
 Experience in translation is preferred
 </li>
 <li>
 Fluent in Arabic &amp; English, French is a plus
 </li>
 </ul>
</div>

Scientific & Regulatory Affairs Specialist – Africa & Trading

Deloitte

<div>
 
 About Deloitte
 
 : When you work for us, you commit to a career at one of the largest and most prestigious professional services firms in the world. We have received numerous awards over the last few years, including Best Employer in the Middle East, and Best Consulting Firm, and the Middle East Training &amp; Development Excellence Award.
 
 
 
 Our Purpose
 
 
 
 Deloitte makes an impact that matters. Every day we challenge ourselves to do what matters most&mdash;for clients, for our people, and for society. We serve clients distinctively, bringing innovative insights, solving complex challenges and unlocking sustainable growth. We inspire our talented professionals to deliver outstanding value to clients, providing an exceptional career experience and an inclusive and collaborative culture. We contribute to society, building confidence and trust in the markets, upholding the integrity of organizations and supporting our communities.
 
 
 Our shared values guide the way we behave to make a positive, enduring impact:
 
 
 <ul>
 <li>
 Lead the way
 </li>
 <li>
 Serve with integrity
 </li>
 <li>
 Take care of each other
 </li>
 <li>
 Foster inclusion
 </li>
 <li>
 Collaborate for measurable impact
 
 
 </li>
 </ul>
 During your tenure as Associate &ndash; Regulatory specialist, you will demonstrate and develop your capabilities in the following areas:
 
 
 <ul>
 <li>
 Collect data and reports from the various regulatory partners.
 </li>
 <li>
 Support the regulatory leader with the day-to-day tasks.
 </li>
 <li>
 Perform risk assessments.
 </li>
 <li>
 Establish a process to periodically reassess risks and emerging issues.
 </li>
 <li>
 Perform risk evaluation and mitigation methodologies.
 </li>
 <li>
 Maintain risk registers.
 </li>
 <li>
 Completion and submission of Reports.
 </li>
 <li>
 Stakeholder Management.
 </li>
 <li>
 Assist in framework implementation.
 </li>
 <li>
 Address questions of colleagues in relation to regulatory matters in a timely manner.
 </li>
 <li>
 Arrange meetings and minutes.
 
 
 </li>
 </ul>
 
 Leadership Capabilities
 
 
 
 <ul>
 <li>
 Builds own understanding of our purpose and values; explores opportunities for impact.
 </li>
 <li>
 Demonstrates strong commitment to personal learning and development; acts as a brand ambassador to help attract top talent
 </li>
 <li>
 Understands expectations and demonstrates personal accountability for keeping performance on track
 </li>
 <li>
 Actively focuses on developing effective communication and relationship-building skills
 </li>
 <li>
 Understands how their daily work contributes to the priorities of the team and the business.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Degree from a reputable University in Risk Management, Accounting, Finance, Business Administration, Commercial Law, or a related field.
 </li>
 <li>
 0 to 2 years of experience.
 </li>
 <li>
 Strong knowledge of risks&rsquo; identification, assessment, and management frameworks.
 </li>
 <li>
 Strong knowledge of control frameworks, and the ability to design and evaluate effectiveness of controls embedded within business processes.
 </li>
 <li>
 Communication and data visualization skills.
 </li>
 <li>
 High analytical skills with strong attention to detail.
 </li>
 <li>
 Strong computer literacy, including Microsoft Word, Excel, PowerPoint.
 </li>
 <li>
 Strong presentation skills.
 </li>
 <li>
 Excellent organizational and planning skills.
 </li>
 <li>
 Ability to understand broader business issues.
 </li>
 <li>
 Excellent command of the English language, both verbal and written.
 </li>
 <li>
 Certification in Governance, Risk and Compliance will be considered an advantage.
 </li>
 <li>
 Fluent in Arabic and English languages.
 </li>
 </ul>
</div>

Associate | Regulatory | QRS | Egypt

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

Konecta

<div>
 
 Firewall Specialist
 
 
 A highly skilled firewall specialist responsible for the
 
 administration, management, and optimization of firewall and network security solutions
 
 to ensure the protection of organizational infrastructure and data. The role focuses on maintaining secure network boundaries, enforcing security policies, and responding to security incidents.
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Manage and administer firewall technologies, ensuring secure and efficient traffic flow across network environments
 </li>
 <li>
 Configure and maintain firewall rules, policies, and access controls in alignment with security standards
 </li>
 <li>
 Monitor network traffic and security logs to detect, analyze, and respond to potential threats and vulnerabilities
 </li>
 <li>
 Perform regular firewall policy reviews, optimization, and cleanup to maintain efficiency and compliance
 </li>
 <li>
 Manage firewall updates, patching, and firmware upgrades in coordination with change management processes
 </li>
 <li>
 Support incident response activities, including investigation and remediation of security incidents
 </li>
 <li>
 Ensure compliance with organizational and regulatory security requirements
 </li>
 <li>
 Conduct routine health checks, risk assessments, and security audits
 </li>
 <li>
 Maintain accurate documentation of firewall configurations, policies, and operational procedures
 </li>
 </ul>
 
 Collaborate with network,
 
</div>

Firewall Specialist

Explore 186+ Regulatory specialist in Cairo this May. Find roles across top companies and apply now to boost your career.

186 regulatory specialist jobs In Cairo

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Export)

Scientific & Regulatory Affairs Specialist – Africa & Trading

Associate | Regulatory | QRS | Egypt

Regulatory Affairs Study Start Up Specialist I

Firewall Specialist