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associate project manager

regulatory affairs manager

Delta Pharma

<div>
 
 
 📌 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies aligned with
 
 Egyptian regulations for human and veterinary products
 
 .
 </li>
 <li>
 Lead preparation, review, and submission of
 
 CTD dossiers
 
 to the Egyptian Drug Authority.
 </li>
 <li>
 Manage full lifecycle activities including
 
 new registrations, variations, renewals, and re-registration
 
 for both sectors.
 </li>
 <li>
 Act as the primary contact with EDA departments handling
 
 human and veterinary dossiers
 
 .
 </li>
 <li>
 Ensure compliance with all
 
 local laws, decrees, and veterinary-specific regulatory requirements
 
 .
 </li>
 <li>
 Oversee
 
 pilot batch production, stability studies, and bio/clinical or veterinary-specific data requirements
 
 .
 </li>
 <li>
 Coordinate with internal teams (R&amp;D, Quality, Production, Supply Chain) to ensure regulatory alignment.
 </li>
 <li>
 Monitor regulatory updates in Egypt and assess impact on both human and veterinary portfolios.
 </li>
 <li>
 Manage timelines, regulatory risks, and mitigation strategies to ensure timely approvals.
 </li>
 <li>
 Support regulatory inspections and ensure audit readiness.
 </li>
 <li>
 Lead, mentor, and develop regulatory team members.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy.
 </li>
 <li>
 
 13+ years of experience in Regulatory Affairs within Egypt
 
 , covering
 
 both human and veterinary products
 
 .
 </li>
 <li>
 Strong hands-on experience with
 
 EDA systems, submissions, and regulatory pathways
 
 .
 </li>
 <li>
 In-depth knowledge of
 
 CTD structure, lifecycle management, and veterinary regulatory requirements in Egypt
 
 .
 </li>
 <li>
 Proven success in obtaining approvals for both
 
 pharmaceutical and veterinary products
 
 .
 </li>
 <li>
 Excellent leadership, communication, and stakeholder management skills.
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Strong understanding of
 
 EDA platforms
 
 </li>
 <li>
 Strategic regulatory planning across multiple product categories
 </li>
 <li>
 Advanced project management and risk assessment
 </li>
 <li>
 Strong negotiation and authority interaction skills
 </li>
 <li>
 High attention to detail and compliance-driven mindset
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Manager

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

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

Sandoz Egypt

<div>
 
 Major Accountabilities
 
 
 
 <ul>
 <li>
 Receive and implement scientific data from Regulatory Affairs, New Products, or Export departments into artwork designs.
 </li>
 <li>
 Prepare packaging artwork (outer cartons, leaflets, inner/outer labels) in line with production specifications.
 </li>
 <li>
 Lead discussion with relevant functions to check and approve the artwork before submitting on the system.
 </li>
 <li>
 Submit artwork to Regulatory Affairs for review on the relevant artwork management systems
 </li>
 <li>
 Apply required amendments and resubmit artwork for review.
 </li>
 <li>
 Prepare medical leaflets in alignment with the approved Word files from the regulatory affairs team.
 </li>
 <li>
 Develop internal forms and maintain local archive of all artworks with relevant change history.
 </li>
 <li>
 Coordinate with the Supply Chain department regarding packaging material codes.
 </li>
 <li>
 Manage the artwork management systems
 </li>
 <li>
 Follow up with Quality Control and Export departments on the review of supplier proofs.
 </li>
 <li>
 Ensure compliance with company SOPs and regulatory standards for artwork processes.
 
 
 </li>
 </ul>
 
 Key Performance Indicators
 
 
 
 <ul>
 <li>
 Quick and accurate design of artworks according to received requests.
 </li>
 <li>
 Accuracy and compliance of artwork with regulatory and quality standards.
 </li>
 <li>
 Timely implementation of amendments.
 </li>
 <li>
 Effective coordination with internal departments and suppliers.
 </li>
 <li>
 Satisfaction of stakeholders with the quality of delivered artwork.
 
 
 </li>
 </ul>
 
 What You&rsquo;ll Bring To The Role
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Applied Arts, Graphic Design, or related field.
 </li>
 <li>
 Proficiency in design software (Adobe Illustrator, Photoshop, InDesign).
 </li>
 <li>
 Experience and knowledge in artwork management systems like SAP , loftware or similar.
 </li>
 <li>
 3 to 5 years practical experience in artwork and packaging design (preferably in the pharmaceutical industry).
 </li>
 <li>
 Good knowledge of regulations and artwork submission processes.
 </li>
 <li>
 Strong language skills in English.
 </li>
 <li>
 Strong communication and coordination skills.
 </li>
 <li>
 High attention to detail and ability to meet deadlines.
 
 
 </li>
 </ul>
 
 Languages
 
 
 
 <ul>
 <li>
 English.
 
 
 </li>
 </ul>
 Why Sandoz?
 
 
 Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
 
 
 With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
 
 
 Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
 
 
 Join us!
 
 
 
 Commitment To Diversity &amp; Inclusion
 
 
 
 We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
 
 
 #Sandoz
</div>

Regulatory Affairs Artwork Associate

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

<div>
 
 📌
 
 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Prepare and review
 
 CTD dossiers
 
 for submission to the Egyptian Drug Authority.
 </li>
 <li>
 Execute regulatory activities for
 
 new registrations, variations, and renewals
 
 .
 </li>
 <li>
 Follow up with EDA on submitted files and handle
 
 deficiency letters and responses
 
 .
 </li>
 <li>
 Ensure submitted documents comply with
 
 local Egyptian and veterinary requirements
 
 .
 </li>
 <li>
 Coordinate with internal departments (R&amp;D, Quality, Production) to collect required documents.
 </li>
 <li>
 Track submission timelines and maintain proper documentation records.
 </li>
 <li>
 Support pilot batch follow-up and
 
 stability data compilation
 
 .
 </li>
 <li>
 Assist in audit readiness and regulatory documentation support.
 </li>
 <li>
 Guide junior team members on daily regulatory tasks.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy or Veterinary Medicine (Pharmacy preferred).
 </li>
 <li>
 
 7&ndash;13 years of experience
 
 in Regulatory Affairs in Egypt (human &amp; veterinary).
 </li>
 <li>
 Hands-on experience with
 
 EDA submission processes
 
 .
 </li>
 <li>
 Strong knowledge of
 
 CTD format and lifecycle activities
 
 .
 </li>
 <li>
 Experience in handling
 
 deficiency responses and follow-ups
 
 .
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Good organizational and follow-up skills
 </li>
 <li>
 Attention to detail and compliance awareness
 </li>
 <li>
 Ability to manage multiple files simultaneously
 </li>
 <li>
 Basic team supervision
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Section Head

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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