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regulatory affairs specialist

POS Enterprise

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

Regulatory Affairs Specialist

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 &nbsp;
 
 
 
 Job Summary:
 
 
 
 We are seeking a passionate and talented
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 <ul>
 <li>
 Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmaceutical Sciences
 </li>
 <li>
 +2 years of experience in Regulatory Affairs in international Markets.
 </li>
 <li>
 Fluent in English (written &amp; verbal) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
 
 
</div>

PHARAONIA Pharmaceuticals

<div>
 
 
 Job Purpose:
 
 
 
 
 
 <ul>
 <li>
 To prepare, compile, and submit high-quality regulatory documentation to health authorities to gain and maintain marketing authorizations for the company's products. This role ensures that all activities are performed in strict compliance with the applicable regulations for the assigned domain.
 </li>
 </ul>
 
 
 
 
 
 Key Accountabilities and Decision Ownership:
 
 
 
 
 
 <ul>
 <li>
 Compile, format, and review scientific and technical data to prepare regulatory dossiers (e.g., CTD modules) for new products, variations, and renewals.
 </li>
 <li>
 Prepare and manage documentation for international product registrations, including legal documents and responses to queries from foreign agents/authorities.
 </li>
 <li>
 Maintain detailed and organized records of all regulatory submissions, correspondence, and approvals.
 </li>
 <li>
 Review product labeling, leaflets, and promotional materials for regulatory compliance.
 </li>
 <li>
 Stay updated with current regulations and guidance documents relevant to the assigned area.
 </li>
 <li>
 
 (For Senior Specialist)
 
 Mentor junior specialists, handle more complex submissions, and contribute to regulatory strategy discussions.
 </li>
 </ul>
 
 
 
 
 
 Technical &amp; professional qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy or a related Life Science is required.
 </li>
 <li>
 1-3 years of experience in regulatory affairs or a related field (e.g., QA, R&amp;D).
 </li>
 </ul>
 
 
 
 
 
 Skills:
 
 
 
 
 
 <ul>
 <li>
 Technical Writing
 </li>
 <li>
 Organizational Skills
 </li>
 <li>
 Microsoft Office (Word, Excel)
 </li>
 <li>
 Problem-Solving
 </li>
 <li>
 Communication
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Specialist (Export)

IQVIA

<div>New Cairo, Egypt | Full time | Hybrid | R1527954</div>
 <div><div>Job Overview 
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.</div><div>
Essential Functions 
<ul><li>Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;</li><li>Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;</li><li>Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;</li><li>Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;</li><li>Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;</li><li>May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;</li><li>May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;</li><li>May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;</li><li>May prepare and deliver regulatory training to IQVIA small groups or individuals;</li><li>Performs other tasks or assignments, as delegated by Regulatory management;</li></ul></div><div>
Qualifications 
<ul><li>Bachelor's Degree Degree in Lifescience or related discipline Req Or</li><li>Master's Degree Degree in Lifescience or related discipline Req</li><li>At least 3-4 years relevant experience</li><li>Good understanding of the Research and Development process (Chemistry, Manufacturing &amp; Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;</li><li>Possesses a specific regulatory or technical expertise;</li><li>Good, solid interpersonal communication (oral and written) and organisation skills;</li><li>Ability to establish and maintain effective working relationships with coworkers, managers and clients;</li><li>Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;</li><li>Demonstrates self-motivation and enthusiasm;</li><li>Ability to work on several projects, with direction from senior staff as appropriate;</li><li>Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;</li><li>Ability to make decisions on discrete tasks under senior supervision;</li><li>Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;</li><li>Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;</li><li>Problems faced are general and may require understanding of broader set of issues, but typically are not complex;</li><li>Ability to adapt quickly to a rapidly changing environment;</li><li>Applicable certifications and licenses as required by country, state, and/or other regulatory bodies</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Senior Regulatory Affairs Specialist

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

<div><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. 
</div><div></div> 
<div>Key Responsibilities:
</div><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>Scientific and regulatory affairs representation in all projects driven forums 
<li>
</li></ul><div></div> 
<div>Qualifications:
</div><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>

Amgen

<div>
 
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 
 You&rsquo;ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
 
 
 
 Live
 
 
 
 
 What You Will Do
 
 
 
 Let&rsquo;s do this. Let&rsquo;s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :
 
 
 <ul>
 <li>
 Ensures regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements
 </li>
 <li>
 Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
 </li>
 <li>
 Execution of the preparation, delivery, and electronic archiving of documentation for inclusion in local regulatory submissions.
 </li>
 <li>
 Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
 </li>
 <li>
 Reviews promotional and non-promotional materials
 </li>
 <li>
 Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner
 </li>
 <li>
 Partners with international Regulatory Leads (IRL) to support the regulatory development, registration, and lifecycle management of all Amgen molecules
 </li>
 <li>
 Partners with peers to ensure consistency on procedures
 </li>
 <li>
 Assists locally in Healthcare Compliance activities, where applicable
 </li>
 <li>
 Participate in local regulatory process improvements, initiatives, and training
 </li>
 <li>
 Overseas external vendor/contractor relationships, where applicable
 
 
 </li>
 </ul>
 
 Win
 
 
 
 
 What We Expect Of You
 
 
 
 We are all different, yet we all use our unique contributions to serve patients. The Associate Regulatory Affairs professional we seek is a teammate with these qualifications.
 
 
 
 Basic Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor`s degree in Pharmaceutical Science
 </li>
 <li>
 Knowledge of Regulatory Principles
 </li>
 <li>
 Working with policies, procedures and SOP&rsquo;s
 </li>
 <li>
 Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
 </li>
 <li>
 Understanding of drug development
 </li>
 <li>
 Demonstrate ability to work in teams
 </li>
 <li>
 Ability to understand and communicate scientific/clinical information
 
 
 </li>
 </ul>
 
 Preferred Qualifications:
 
 
 
 <ul>
 <li>
 Regulatory experience of the Gulf Markets (1 year experience)
 </li>
 <li>
 Knowledge of legislation and regulations relating to medicinal products in the Gulf Markets.
 
 
 </li>
 </ul>
 
 Thrive
 
 
 
 
 What You Can Expect Of Us
 
 
 
 As we work to develop treatments that take care of others, we also work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
 
 
 
 Apply now
 
 
 
 
 for a career that defies imagination
 
 
 
 Objects in your future are closer than they appear. Join us.
 
 
 
 careers.amgen.com
 
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
 
 
 We will ensure that individuals with disabilities are provided 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 accommodation.
</div>

Associate Regulatory Affairs - based in Egypt

Explore 634+ Regulatory affairs specialist in Egypt this May. Find roles across top companies and apply now to boost your career.

634 regulatory affairs specialist jobs In Egypt

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Export)

Senior Regulatory Affairs Specialist

Scientific & Regulatory Affairs Specialist – Africa & Trading

Scientific & Regulatory Affairs Specialist – Africa & Trading

Associate Regulatory Affairs - based in Egypt