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regulatory affairs manager

EgyBell

<div>
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Monitoring the availability of the basic principles and elements that help develop and improve the company's performance, thus contributing to the achievement of the strategic objectives set by the Board of Directors.
 </li>
 <li>
 Monitoring the application of the principles of disclosure, transparency, and a culture of governance across all the company's business and activities.
 </li>
 <li>
 Improving and developing the company's general framework and operating principles through the company's Code of Professional Conduct.
 </li>
 <li>
 Monitoring the implementation of the conflict-of-interest policy for all company employees.
 </li>
 <li>
 Working to implement the concepts of transparency, clarity, and fairness in dealing with all company shareholders.
 </li>
 <li>
 Working to raise awareness regarding the responsibilities and duties of the company's board of directors and shareholders.
 </li>
 <li>
 Preparing the company's internal governance regulations and formulating its policies, as well as contributing to preparing the annual governance report
 </li>
 </ul>
 
 
 
 
 Additionally:
 
 <ul>
 <li>
 Lead the governance team and oversee daily tasks.
 </li>
 <li>
 Follow up on FRA regulatory updates and ensure implementation across departments.
 </li>
 <li>
 Prepare required regulatory reports and submit them within deadlines.
 </li>
 <li>
 Track corrective action plans and ensure closure of audit or regulatory findings.
 </li>
 <li>
 Record governance-related risks or incidents and follow up on mitigation actions.
 </li>
 <li>
 Prepare reports for senior management.
 </li>
 <li>
 Conduct awareness sessions for employees regarding governance updates and policies.
 </li>
 </ul>
 
 
 
 
 
 Qualifications:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in law is a plus, or related field.
 </li>
 <li>
 10-13 years of experience in Governance, Corporate Secretariat, Head of Ethics Committee, Compliance (insurance experience preferred).
 </li>
 <li>
 Proficient English, both spoken and written.
 </li>
 <li>
 Proficiency in MS Office.
 </li>
 <li>
 Excellent interpersonal, leadership and directing skills.
 </li>
 <li>
 High sense of judgment, accuracy, scrutiny and analysis.
 </li>
 <li>
 Strong analytical and organizational skills.
 </li>
 </ul>
 
 
 
 
 
 
 <ul>
 <li>
 Proficient and have the relevant expertise in internal audit standards and techniques.
 </li>
 <li>
 Ability to work under pressure.
 </li>
 <li>
 Good leadership and communication abilities.
 </li>
 </ul>
</div>

Governance & Regulatory Affairs Manager

Grifols Egypt for Plasma Derivatives (GEPD)

<div>
 
 Job Objective:
 
 
 
 Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).
 
 
 Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).
 
 
 
 Key responsibility:
 
 
 
 <ul>
 <li>
 Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
 </li>
 <li>
 Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
 </li>
 <li>
 Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
 </li>
 <li>
 Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
 </li>
 <li>
 Change notification to Local and International Health Authorities.
 </li>
 <li>
 Change notification and customers related to Change Control implementation.
 </li>
 <li>
 To assist Direct Manager in any assigned duties.
 </li>
 <li>
 Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
 </li>
 <li>
 Post-Graduate Certification in Quality Management.
 </li>
 <li>
 Knowledge of cGMP requirements preferred.
 </li>
 <li>
 Minimum of 4 years of Management or technical leadership experience is required.
 </li>
 <li>
 Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
 </li>
 <li>
 Manufacturing background, and Final Product importation and exportation experience.
 </li>
 <li>
 Preferably with experience on EMA Regulatory requirements and submissions.
 
 </li>
 </ul>
</div>

Regulatory Affairs Sr. Manager

Jamjoom Pharma

<div>
 
 Role Overview
 
 
 
 We are seeking a detail-oriented and proactive
 
 Export Regulatory Affairs Specialist
 
 with mandatory fluency in French and English to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.
 </li>
 <li>
 Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.
 </li>
 <li>
 Ensure compliance with export regulations, customs requirements, and country-specific guidelines.
 </li>
 <li>
 Liaise with agents, distributors, and internal teams to resolve regulatory queries.
 </li>
 <li>
 Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.
 </li>
 <li>
 Support audits, inspections from export countries.
 </li>
 <li>
 Develop and optimize workflows for regulatory submissions and export documentation.
 
 
 </li>
 </ul>
 
 Qualifications &amp; Requirements
 
 
 
 
 Education
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Life Sciences, or a related field (mandatory).
 </li>
 <li>
 Additional training or certification in Regulatory Affairs is considered a plus.
 
 
 </li>
 </ul>
 
 Experience
 
 
 
 <ul>
 <li>
 3&ndash;5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on export submissions.
 </li>
 <li>
 Proven experience in CTD/eCTD dossier preparation, publishing, and submission for international markets.
 </li>
 <li>
 Solid knowledge of international regulatory requirements and export-related guidelines.
 </li>
 <li>
 Experience working with agents and distributors across multiple countries is an advantage.
 </li>
 <li>
 Fluency in French is a must (written and spoken).
 </li>
 <li>
 Fluency in English (written and spoken)
 
 
 </li>
 </ul>
 
 Skills &amp; Competencies
 
 
 
 <ul>
 <li>
 Regulatory Expertise: Strong understanding of global regulatory frameworks and export compliance requirements.
 </li>
 <li>
 Technical Writing: Excellent ability to prepare clear, accurate, and compliant regulatory documentation.
 </li>
 <li>
 Communication: Fluent in English (written and spoken); French language skills are required.
 </li>
 <li>
 Organization &amp; Attention to Detail: High level of accuracy in managing multiple dossiers and regulatory documents.
 </li>
 <li>
 Cross-functional Collaboration: Ability to work effectively with internal teams and external partners.
 </li>
 <li>
 Systems &amp; Tools: Proficient in documentation management systems and MS Office applications.
 </li>
 <li>
 Problem Solving: Proactive in identifying issues and driving timely regulatory solutions.
 </li>
 <li>
 Integrity &amp; Compliance: Demonstrates strong ethical standards and commitment to regulatory compliance.
 </li>
 </ul>
</div>

Export Regulatory Affairs specialist (French)

AstraZeneca

<div>
 
 
 Play a key role in bringing innovative medicines to patients. Join AstraZeneca&rsquo;s Regulatory Affairs team and help navigate the regulatory pathway that supports the development, approval, and lifecycle management of impactful therapies.
 
 
 
 
 
 About Astrazeneca
 
 
 
 AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world&rsquo;s most serious diseases. But we&rsquo;re more than one of the world&rsquo;s leading pharmaceutical companies.
 
 
 Join a high-performing team, empowered to cut through the noise and drive real change. Our agility and pace, coupled with scientific focus, powers us to spot opportunities in the market that keep us moving forward and into new spaces.
 
 
 
 Why AstraZeneca?
 
 
 
 At AstraZeneca we&rsquo;re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There&rsquo;s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We&rsquo;re on an exciting journey to pioneer the future of healthcare.
 
 
 
 About The Role
 
 
 
 
 Job Purpose:
 
 
 
 As a Regulatory Affairs Senior Specialist, you will be responsible for supporting the development and execution of global regulatory strategies to ensure timely approval and lifecycle management of AstraZeneca&rsquo;s products. This role collaborates cross-functionally with clinical, medical, and commercial teams to ensure regulatory compliance while enabling efficient delivery of innovative medicines to patients.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Support the preparation and submission of regulatory dossiers to the health authorities.
 </li>
 <li>
 Contribute to the development and implementation of regulatory strategies across product registrations &amp; lifecycles for NEMAG markets mainly Iraq &amp; Palestine.
 </li>
 <li>
 Ensure regulatory submissions comply with regional and international guidelines and standards.
 </li>
 <li>
 Coordinate with cross-functional teams including clinical development, safety, and quality.
 </li>
 <li>
 Maintain accurate regulatory documentation and submission records.
 </li>
 <li>
 Track regulatory commitments and support responses to health authority queries.
 </li>
 <li>
 Monitor evolving regulatory requirements and communicate potential impacts to stakeholders.
 </li>
 <li>
 Assist with new products &amp; manufacturing sites registration &amp; lifecycle management activities including variations, renewals &amp; label updates.
 </li>
 <li>
 Support preparation for regulatory meetings and health authority interactions.
 </li>
 <li>
 Contribute to continuous improvement initiatives within the Regulatory Affairs function.
 
 
 </li>
 </ul>
 
 Job Requirements
 
 
 
 
 Essential Criteria:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy or any other scientific discipline.
 </li>
 <li>
 A minimum of 3 years of experience in Regulatory Affairs in a multinational pharmaceutical company.
 </li>
 <li>
 Proficiency in Arabic and English language is a must.
 </li>
 <li>
 Strong communication, presentation, and negotiation, with the ability to convey complex information clearly and inspire cross-functional collaboration.
 </li>
 <li>
 Proficiency in Microsoft Office.
 </li>
 <li>
 Regulatory fundamentals knowledge.
 </li>
 <li>
 Flexible for travel upon business need.
 
 
 </li>
 </ul>
 
 Preferred Criteria
 
 
 
 <ul>
 <li>
 Regional Regulatory Affairs experience (mainly Iraq).
 </li>
 <li>
 Vault System knowledge.
 
 
 </li>
 </ul>
 
 
 Please note that this position is based in Cairo and is not open for relocation; only apply if you are located in or can easily access this location.
 
 
 
 
 
 Where can I find out more?
 
 
 
 Our Social Media,
 
 
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 
 
 Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
 
 
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
 
 
 
 Date Posted
 
 
 
 09-Mar-2026
 
 
 
 Closing Date
 
 
 
 15-Mar-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>

Regulatory Affairs Sr. Specialist - NEMAG

Fresenius Medical Care

<div>
 At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision&mdash;&ldquo;Creating a future worth living. For patients. Worldwide. Every day.&rdquo;&mdash;we work with purpose and compassion, supported by a global team of over 125,000 employees.
 
 
 Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
 
 
 Our values guide how we work:
 
 
 
 <ul>
 <li>
 We Care for our patients, each other, and our communities
 </li>
 <li>
 We Connect across teams and borders to deliver excellence together
 </li>
 <li>
 We Commit to doing things the right way&mdash; growing with purpose and leading kidney care with integrity and innovation
 
 
 
 </li>
 </ul>
 Systems, Quality &amp; Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care&rsquo;s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!
 
 
 Your Responsibilities:
 
 
 
 <ul>
 <li>
 Perform all country/region regulatory activities, ensuring product conformity, safety, post-market surveillance, and alignment with corporate SysQaRa and Quality functions
 </li>
 <li>
 Drive market access by preparing/adapting registration dossiers, managing submissions with consultants/TPIs, supporting due diligence, and enabling timely, compliant approvals for new and existing products
 </li>
 <li>
 Act as the primary regulatory key person, providing strategic guidance, risk assessments, and updates on national/regional regulatory requirements, while ensuring internal implementation and database maintenance
 </li>
 <li>
 Submitting notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
 </li>
 <li>
 Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
 </li>
 <li>
 Create and maintain local/regional registration database
 </li>
 <li>
 Identify regulatory and compliance risks, propose mitigation strategies, and track CAPAs resulting from internal or TPI audits
 </li>
 <li>
 Serve as PVRP or PV contact for assigned countries, interfacing with authorities, healthcare professionals, distributors, and CDS, and acting as the PV lead during audits/inspections
 </li>
 <li>
 For countries acting as PVRP, preparation of CAPAs for audit findings and process deviations, collection and forwarding of AE/ADRs and completion of quarterly compliance reports; for countries acting as PV point of contact, ensure preparation of CAPAs for audit findings and process deviations by the distributor and/or consultant, follow up of necessary AE/ADR collection and quarterly compliance report preparations to be performed by the related TPIs/contractors.
 </li>
 <li>
 Performing implementation and maintenance of Pharmacovigilance Agreements
 
 
 
 </li>
 </ul>
 Your Profile:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy, Chemistry, Biology, Bioengineering, Health Sciences, or another relevant scientific discipline
 </li>
 <li>
 At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
 </li>
 <li>
 Results-driven professional with a structured approach, strong problem-solving and analytical skills, and the ability to handle pressure and prioritize effectively. Excellent communicator, independent worker, and solution-focused in achieving quality outcomes
 </li>
 <li>
 Demonstrated drive for process improvement and continuous optimization
 </li>
 <li>
 Solid knowledge of pharmacovigilance and pharmaceutical legislation
 </li>
 <li>
 Proficient in English (spoken and written)
 
 
 
 </li>
 </ul>
 Our Offer for you:
 
 
 There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
 
 
 
 <ul>
 <li>
 Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
 </li>
 <li>
 Individual opportunities for self-determined career planning and professional development
 </li>
 <li>
 A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
 </li>
 <li>
 A large number of committed people with a wide range of skills, talents and experience
 </li>
 <li>
 The benefits of a successful global corporation with the collegial culture of a medium-sized company
 </li>
 </ul>
</div>

Regulatory and Pharmacovigilance Senior Expert

<div>
 <ul>
 <li>
 Support the implementation of the Compliance Program across all departments, ensuring alignment with corporate and global compliance standards.
 </li>
 <li>
 Assist in conducting risk assessments, monitoring activities, and compliance audits, and follow up on corrective and preventive actions (CAPAs).
 </li>
 <li>
 Facilitates the management of Third Party interacting on behalf of GEPD, coordinating background checks on vendors, preparing comprehensive reports in accordance with due diligence processes.
 </li>
 <li>
 Maintain and update compliance-related documentation, including SOPs, training records, and assurance reports.
 </li>
 <li>
 Coordinate training sessions to promote awareness of ethics, compliance policies.
 </li>
 <li>
 Monitor and report on compliance metrics, highlighting potential gaps or process deviations.
 </li>
 <li>
 Liaise with internal stakeholders (Commercial, HR, Medical Affairs, etc.) to ensure smooth execution of compliance requirements.
 </li>
 <li>
 Provide assistance in preparing for inspections and audits, ensuring readiness and proper documentation.
 </li>
 <li>
 Participate in investigations and documentation of non-compliance events, ensuring corrective actions are tracked and closed.
 </li>
 <li>
 Promote a culture of ethics, integrity, inclusion, and transparency in all business activities.
 </li>
 <li>
 Serve as a point of contact for employees seeking clarification on compliance procedures or reporting obligations.
 </li>
 </ul>
 
 
 Academic &amp; Professional experience required
 
 
 <ul>
 <li>
 Bachelors degree in Pharmacy, Law, Business Administration, or a related discipline.
 </li>
 <li>
 7 plus years of experience in a control function e.g. Medical affairs, Quality, or Regulatory affairs (preferably in the pharmaceutical or healthcare sector), at least 2&ndash;4 years of which is in compliance.
 </li>
 <li>
 Strong understanding of compliance frameworks, SOP management, and audit processes
 </li>
 <li>
 Proficient in Microsoft Office and reporting tools.
 </li>
 <li>
 Very Good English
 </li>
 </ul>
</div>

Corporate Compliance Lead

<div>
 <ul>
 <li>
 Support the implementation of the Compliance Program across all departments, ensuring alignment with corporate and global compliance standards.
 </li>
 <li>
 Assist in conducting risk assessments, monitoring activities, and compliance audits, and follow up on corrective and preventive actions (CAPAs).
 </li>
 <li>
 Facilitates the management of Third Party interacting on behalf of GEPD, coordinating background checks on vendors, preparing comprehensive reports in accordance with due diligence processes.
 </li>
 <li>
 Maintain and update compliance-related documentation, including SOPs, training records, and assurance reports.
 </li>
 <li>
 Coordinate training sessions to promote awareness of ethics, compliance policies.
 </li>
 <li>
 Monitor and report on compliance metrics, highlighting potential gaps or process deviations.
 </li>
 <li>
 Liaise with internal stakeholders (Commercial, HR, Medical Affairs, etc.) to ensure smooth execution of compliance requirements.
 </li>
 <li>
 Provide assistance in preparing for inspections and audits, ensuring readiness and proper documentation.
 </li>
 <li>
 Participate in investigations and documentation of non-compliance events, ensuring corrective actions are tracked and closed.
 </li>
 <li>
 Promote a culture of ethics, integrity, inclusion, and transparency in all business activities.
 </li>
 <li>
 Serve as a point of contact for employees seeking clarification on compliance procedures or reporting obligations.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelors degree in Pharmacy, Law, Business Administration, or a related discipline.
 </li>
 <li>
 7 plus years of experience in a control function e.g. Medical affairs, Quality, or Regulatory affairs (preferably in the pharmaceutical or healthcare sector), at least 2&ndash;4 years of which is in compliance.
 </li>
 <li>
 Strong understanding of compliance frameworks, SOP management, and audit processes
 </li>
 <li>
 Proficient in Microsoft Office and reporting tools.
 </li>
 <li>
 Very Good English
 
 </li>
 </ul>
</div>

Explore 253+ Regulatory affairs manager in Cairo this March. Find roles across top companies and apply now to boost your career.

253 regulatory affairs manager jobs In Cairo

Governance & Regulatory Affairs Manager

Regulatory Affairs Sr. Manager

Export Regulatory Affairs specialist (French)

Regulatory Affairs Sr. Specialist - NEMAG

Regulatory and Pharmacovigilance Senior Expert

Corporate Compliance Lead

Corporate Compliance Lead