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regulatory affairs specialist

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>
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 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.
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 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.
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 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.
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 Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
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 Change notification to Local and International Health Authorities.
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 Change notification and customers related to Change Control implementation.
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 To assist Direct Manager in any assigned duties.
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 Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
 
 
 
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 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
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 Post-Graduate Certification in Quality Management.
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 Knowledge of cGMP requirements preferred.
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 Minimum of 4 years of Management or technical leadership experience is required.
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 Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
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 Manufacturing background, and Final Product importation and exportation experience.
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 Preferably with experience on EMA Regulatory requirements and submissions.
 
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 </ul>
</div>

Regulatory Affairs Sr. Manager

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>
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 We Care for our patients, each other, and our communities
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 We Connect across teams and borders to deliver excellence together
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 We Commit to doing things the right way&mdash; growing with purpose and leading kidney care with integrity and innovation
 
 
 
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 </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
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 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
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 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
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 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
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 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.
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 Create and maintain local/regional registration database
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 Identify regulatory and compliance risks, propose mitigation strategies, and track CAPAs resulting from internal or TPI audits
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 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
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 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.
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 Performing implementation and maintenance of Pharmacovigilance Agreements
 
 
 
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 </ul>
 Your Profile:
 
 
 
 <ul>
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 Bachelor&rsquo;s degree in Pharmacy, Chemistry, Biology, Bioengineering, Health Sciences, or another relevant scientific discipline
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 At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
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 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
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 Demonstrated drive for process improvement and continuous optimization
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 Solid knowledge of pharmacovigilance and pharmaceutical legislation
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 Proficient in English (spoken and written)
 
 
 
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 </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.
 
 
 
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 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
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 Individual opportunities for self-determined career planning and professional development
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 A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
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 A large number of committed people with a wide range of skills, talents and experience
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 The benefits of a successful global corporation with the collegial culture of a medium-sized company
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 </ul>
</div>

Regulatory and Pharmacovigilance Senior Expert

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

Corporate Compliance Lead

Minapharm Pharmaceuticals

<div>
 
 
 
 
 About Minapharm:
 
 
 
 
 
 Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering.
 
 
 
 
 
 Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline.
 
 
 
 
 
 Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO; Minapharm has established an integrated business model making it the only gene-to-market company in the region.
 
 
 
 
 
 Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, have incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
 
 
 
 
 
 Minapharm Group of Pharmaceutical Companies employ a collective workforce of more than 1400 individuals &amp; continue to expand their workforce with Talented Human Capital
 
 
 
 
 
 
 
 
 Our Core Values:
 
 
 
 
 
 &middot; Diversity &amp; Respect
 
 
 &middot; Integrity &amp; Accountability
 
 
 &middot; Collaboration
 
 
 &middot; Leadership &amp; Empowerment
 
 
 &middot; Innovation &amp; Continuous Learning
 
 
 
 
 
 
 Job Mission :
 
 
 
 Successful job Holder will handle all related new registration/re-registration/variation files of Minapharm/MiGenTra products, ensuring compliance with Egyptian Drug Authority (EDA) guidelines to secure marketing authorizations. Key missions include preparing and submitting registration dossiers &amp; handling renewals and variations.
 
 
 
 
 
 
 Duties &amp; Responsibilities
 
 :
 
 
 Regulatory Affairs - Manufacturing Sector
 
 
 &bull; Plan EDA Visits and communicate with EDA inspector(S).
 
 
 &bull; Ensure compliance with regulations set by EDA.
 
 
 &bull; Prepare and submit all documents and reports requested by the EDA.
 
 
 &bull; Prepare requirement to be ready on time; from QC Department in the Preparation of COAs and reference standards needed to be submitted with finished products samples to center lab NODCAR(&amp;or) Bio - inn
 
 
 &bull; Follow with validation department the submitting of the first three batches for any newly registered product.
 
 
 &bull; Follow Raw Materials upcoming RMs and their documents to facilitate EDA release process.
 
 
 &bull; Archive all the registration documents, EDA reports, samples &amp; COAs for products submitted to NODCAR (&amp;/OR) Bio-Inn.
 
 
 &bull; Follow all NODCAR (&amp;/OR) Bio-Inn requirements for samples submitted to Central lab (EDA)
 
 
 &bull; Handle EDA audits.
 
 
 &bull; Prepare a complete file for each product to contain all documents sent by Registration department
 
 
 &bull; Perform any additional tasks as requested and review Master Files, Drawings, Files related to EDA requirements.
 
 
 
 
 
 
 Qualifications (Educational Background &amp; Preferred work Experience)
 
 :
 
 
 -Not less than 6-9 years in relevant experience.
 
 
 -Education Background : Bachelor&rsquo;s degree in Pharmaceutical sciences is a must.
 
 
 -Training: Training workshops held by EDA or external parties dealing with new/existing law or guidelines related to registration in Egypt.
 
 
 
 
 
 -
 
 Functional / Technical Competencies
 
 : Strong Expertise in the following:
 
 
 &bull;Guidelines of registration process.
 
 
 &bull;Inspection/licensing procedures/ different registration ministerial decree/procedures of different registration submission (stability/pharmacology/naming/variation)
 
 
 
 
 
 -
 
 Behavioral Competencies
 
 :
 
 
 &bull; Business Acumen
 
 
 &bull;Good Communication Skills
 
 
 &bull; Previous proven previous close interaction with Egyptian Drug Authority (EDA)
 
 
 
 
 
 
 Additional Skills:
 
 
 
 &bull; Computer Skills Literacy (familiar with word/excel/PP).
 
</div>

Regulatory Affairs Expert

Jamjoom Pharma

<div>
 Jamjoom Pharma is seeking a seasoned legal leader to oversee our legal affairs across international markets. Reporting directly to the Group Legal Director in KSA, you will spearhead legal strategy, corporate governance, and risk management across our international operations&mdash;ensuring legal excellence and business alignment in fast-evolving environments.
 
 
 
 Key Responsibilities
 
 
 
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 Provide strategic legal counsel across multiple jurisdictions, supporting commercial, regulatory, IP, and employment matters
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 Participate in strategic planning forums across countries and clusters, aligning legal input with core business objectives
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 Lead contract lifecycle management and intellectual property oversight including trademarks portfolio
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 Ensure robust governance across subsidiaries, including board resolutions, filings, and policy implementation
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 Advise on legal compliance, risk mitigation, and emerging regulatory matters including cybersecurity and data protection
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 <li>
 Collaborate with internal stakeholders and manage external counsel for litigation and specialized matters
 
 
 </li>
 </ul>
 
 Qualifications Required
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in law
 </li>
 <li>
 Minimum 10 years as in-house counsel
 </li>
 <li>
 Fluent in Arabic and English (written and verbal)
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 LLM or equivalent postgraduate legal degree
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 <li>
 Licensed to practice law in a Middle Eastern jurisdiction
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 Experience within the pharmaceutical or similar regulatory industry
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 <li>
 Proficiency in French
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 <li>
 Deep expertise in commercial, contract, and corporate law
 </li>
 <li>
 Strong business acumen and ability to offer commercially sound legal solutions
 </li>
 </ul>
</div>

Senior Legal Manager

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146 regulatory affairs specialist jobs In Cairo

Regulatory Affairs Sr. Manager

Regulatory Affairs Sr. Manager

Regulatory and Pharmacovigilance Senior Expert

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Regulatory Affairs Expert

Senior Legal Manager

Senior Legal Manager