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>

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)

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

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

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

dLocal

<div>
 
 What&rsquo;s the opportunity?
 
 
 
 As our Regulatory and Licensing Officer based in with the MENA region, you will support all Compliance and Regulatory matters related to Dlocal&rsquo;s business and operation and will help maintain oversight for Dlocal&rsquo;s legal entities. In this role, you will help enable business growth while serving as a gatekeeper to prevent regulatory, legal, and reputational harm.
 
 
 
 What will I be doing?
 
 
 
 <ul>
 <li>
 Provides legal knowledge and expertise on financial, payments, and fintech regulations in MENA countries
 </li>
 <li>
 Provide effective advice to all the internal teams to find solutions and identify potential risks on implementing the regulatory requirements for Dlocal's entities, advising in any regulatory impact from the initial stage to the end, enabling the business to scale and grow
 </li>
 <li>
 Advice relevant stakeholders in identifying laws and regulations that could impact to the company, training on material and method to be used, assessing training competence, and monitoring adherence to and compliance with training plans
 </li>
 <li>
 Advise line management on possible legal and regulatory impact across all divisions of regulatory developments and trends while highlighting potential revenue generation/cost-saving opportunities
 </li>
 <li>
 Liaising with relevant stakeholders across Dlocal&acute;s business divisions to drive compliance with identified regulatory and statutory requirements and obligations
 </li>
 <li>
 Supporting activities to create company-wide awareness of regulatory and statutory requirements and the importance of complying with these requirements
 </li>
 <li>
 Contribute to drafting company policies and internal processes
 </li>
 <li>
 Maintaining a compliance calendar and submitting legal and regulatory returns when due, in collaboration with the respective teams
 </li>
 <li>
 Assess and continuously advise the respective departments on AML &amp; CFT, Data Privacy, and fintech regulations
 
 
 
 </li>
 </ul>
 
 What skills do I need?
 
 
 
 <ul>
 <li>
 Advanced degree in (preferably) law, compliance, finance, or a comparable study
 </li>
 <li>
 5+ years experience in a regulatory or compliance officer role or legal advisor
 </li>
 <li>
 You are fluent in English and Arabic (written and spoken) is mandatory
 </li>
 <li>
 Experience gained in an international company, Payments, financial institution, or law firm is a must
 </li>
 <li>
 Highly analytical with strong attention to detail
 </li>
 <li>
 Professional, flexible, and highly responsible and hands-on
 
 
 
 </li>
 </ul>
 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
</div>

Regulatory and Licensing Officer - MENA

AstraZeneca

<div>
 
 Job Title: Nominated Signatory &amp; Medical Excellence Lead
 
 
 
 
 Introduction To Role
 
 
 
 Are you ready to uphold the highest standards of medical governance while accelerating field excellence to deliver better outcomes for patients? This role places you at the center of ethical decision-making and capability building, ensuring that every activity, material, and interaction reflects our standards and enables impact at pace.
 
 
 You will bridge rigorous compliance with practical execution, helping teams move fast and do the right thing. Can you translate strategy into measurable improvements that raise the quality and reach of medical engagement? Join us to combine science, ethics, and operational excellence in a dynamic environment where bold ideas and disciplined delivery go hand in hand.
 
 
 
 Accountabilities
 
 
 
 <ul>
 <li>
 Ethical Interactions Governance: Own and maintain local Ethical Interactions (EI) SOPs; translate global Code of Conduct into robust local procedures covering patient interactions, digital communications, diagnostics, patient affordability, and external funding.
 </li>
 <li>
 Nominated Signatory Leadership: Lead a team of risk assurance managers/signatories; review and approve materials and activities to meet ABAC, data privacy, local regulatory, and company standards; sign HCP/HCO agreements on behalf of the business.
 </li>
 <li>
 External Funding Oversight: Chair the Ethical Interactions Committee; assess, approve, and monitor external funding and third‑party engagements, ensuring transparency, fairness, and appropriate documentation.
 </li>
 <li>
 Risk and Assurance: Conduct first-line monitoring and quality checks; partner with Compliance and Assurance to execute risk assessments, define CAPAs, and track remediation to closure with evidence and sustainability plans.
 </li>
 <li>
 Medical Quality and Standards: Guide medical and marketing collaboration to ensure scientific accuracy, fair balance, and adherence to codes and SOPs across congresses, advisory boards, digital engagement, and field medical activities.
 </li>
 <li>
 Digital Compliance: Govern compliant HCP digital engagement platforms and content, ensuring consent, privacy-by-design, and appropriate content governance across channels.
 </li>
 <li>
 Process Improvement: Drive simplification and continuous improvement of governance processes, templates, and systems; embed controls proportionate to risk while enabling business agility.
 </li>
 <li>
 Cross-Functional Partnership: Advise cross‑functional teams on ethical and governance considerations for complex initiatives, mega events, and interactions with government officials.
 </li>
 <li>
 Medical Excellence: Purpose Elevate Medical Affairs capability across Egypt by defining competency standards, driving robust onboarding and continuous development for Medical Science Liaisons (MSLs) and Medical Advisors, and owning certification and quality assurance to improve scientific engagement, evidence generation readiness, and cross-functional impact.
 </li>
 <li>
 Liaise with the Global &amp; International Medical Excellence Team in connection to excellence programs, localize relevant initiatives to Egypt market as aligned with local strategy and compliance, and seek out opportunities for cross-market collaboration.
 </li>
 <li>
 Improve scientific engagement quality, call planning, narratives, objection handling, compliant interactions, and insight capture/translation.
 </li>
 <li>
 Equip medical managers with coaching requirements as per AZ standards.
 
 
 </li>
 </ul>
 
 Essential Skills/Experience
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree in pharmacy or related life sciences field required.
 </li>
 <li>
 Experience: 7+ years in Medical Affairs/Compliance/Governance within pharma, including direct Nominated Signatory or equivalent approval authority.
 </li>
 <li>
 Expertise: Strong knowledge of ABAC, Data Privacy, EI codes, GxP fundamentals, and Egypt regulatory frameworks; audit and CAPA lifecycle management; digital engagement governance.
 </li>
 <li>
 Risk assessment, SOP authorship, stakeholder management, training design/delivery, analytical problem solving, change management, and clear written/oral communication in English
 
 
 </li>
 </ul>
 
 Desirable Skills/ Experience
 
 
 
 <ul>
 <li>
 Certifications : GCP/GVP quality, compliance auditing, data privacy, or ABAC training.
 </li>
 <li>
 Medical Excellence Manager Experience
 
 
 </li>
 </ul>
 
 Why AstraZeneca
 
 
 
 Join a team that blends scientific rigor with commercial precision to launch innovations that matter to patients, moving from early diagnosis through treatment with an unwavering ethical core. We operate at pace in evolving markets with the freedom to experiment, learn, and improve, bringing surprising combinations of people together to spark bold thinking. We value kindness alongside ambition, and we follow the evidence to deliver solutions that serve patients and the business without compromising on doing the right thing. Your contribution will shape a connected healthcare ecosystem through partnerships and practical innovation, powered by a science-led pipeline that keeps learning fresh and impact real.
 
 
 
 Call To Action
 
 
 
 Step forward to lead medical governance and excellence&mdash;bring your rigor and creativity to power faster, safer decisions and create meaningful patient impact!
 
 
 
 Date Posted
 
 
 
 08-مارس-2026
 
 
 
 Closing Date
 
 
 
 31-مارس-2026
 
 
 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
</div>

Nominated Signatory & Medical Excellence Lead

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