global regulatory affairs manager

Amgen

<div><div>Egypt - Cairo
<div>JOB ID: R-241891 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Apr. 08, 2026 CATEGORY: Regulatory
</div></div><div><div><h2 class="jobSectionHeader">HOW MIGHT YOU DEFY IMAGINATION?</h2><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 achievetogether&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><h2 class="jobSectionHeader">
Job purpose:</h2><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><h2 class="jobSectionHeader">
Job Responsibilities:</h2><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><h2 class="jobSectionHeader">
Qualifications:</h2><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><h2 class="jobSectionHeader">
 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.</h2></div></div></div>

MEA Regulatory Affairs Senior Associate

<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>

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>

TAQWA PHARMA

Job Opportunity: Regulatory Affairs ManagerWe are looking for a dynamic and self-driven Regulatory Affairs Manager to spearhead our documentation and compliance department. We need a proactive professional with a sharp eye for detail who can take full ownership of our international dossier pipeline and drive high-stakes projects to completion.Key Responsibilities<ul><li>Dossier Mastery: Lead the end-to-end preparation, compilation, and technical checking of ASEAN Common Technical Dossiers (ACTD).</li><li>Export Compliance: Oversee and verify HOTC export dossiers to ensure seamless international submissions and approvals.</li><li>Quality Leadership: Act as the final authority on technical accuracy, ensuring all documentation is 100% compliant with global Ministry of Health standards.</li><li>Strategic Workflow: Manage timelines with high energy, ensuring that registration goals for international markets are met efficiently.</li></ul>Required Qualifications<ul><li>Experience: Minimum of 5 years of proven experience in Pharmaceutical Regulatory Affairs.</li><li>Technical Expertise: Specialized knowledge in ACTD formats and international export documentation.</li><li>Education: B.Pharm, Pharm.D, or a relevant Master&rsquo;s degree.</li><li>Core Attributes: We are seeking a young and energetic individual who is career-oriented and capable of working with minimal supervision.</li></ul>Compensation &amp; Benefits<ul><li>Salary: Market-competitive salary package based on experience and technical expertise.</li><li>Growth: Opportunities for professional development in a growing international business environment.</li></ul>Job Details<ul><li>Location: Karachi (Office conveniently located near the Karachi Chamber of Commerce and Industry).</li><li>Gender: Open to both Male and Female candidates.</li><li>Type: Full-time.</li></ul>Experience:<ul><li>regulatory manager: 4 years (Required)</li></ul>Work Location: In person

Regulatory Manager - Pharmaceutical

<div><div>Egypt - Cairo
<div>JOB ID: R-243855 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Apr. 28, 2026 CATEGORY: Regulatory
</div></div><div><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>
Regulatory Affairs Manager| ELI
Job Responsibilities:<ul><li>
High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.</li><li>
Maintain established products according to global and local regulatory plans.</li><li>
Update and maintain regulatory databases.</li><li>
Handle Health Authorities requests.</li><li>
Build and keep a highly professional relationship with the Medicines Agency.</li><li>
Support and interact with global regulatory affairs, QA, Market Access, Marketing (projects and product teams) and Sales to best support local and global strategy.</li><li>
Monitor future trends in regulatory affairs which are likely to affect AMGEN interest.</li><li>
Perform or facilitate audits to ensure compliance</li></ul>
Qualifications:
<ul><li>A bachelor&rsquo;s degree in Pharmacy or any relevant field.</li><li>
Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities.</li><li>
Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.</li><li>
Advanced ability to interpret scientific data and to construct persuasive regulatory documents.</li><li>
Good communication skills, ability to work effectively in a matrix setup.</li><li>
Strong knowledge of regulatory life cycle maintenance.</li><li>
Having People Management experience is critical.</li><li>
An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken.
</li><li>Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals.</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>
 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></div></div>

Regulatory Affairs Manager| ELI

Arcera Life Sciences

<div>
 
 Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
 
 
 
 
 
 This position is based in
 
 Cairo, Egypt
 
 and will report directly to the
 
 Regulatory Affairs Lead, GULF.
 
 The role will be responsible to support the RA Lead on all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman and Qatar). Ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs as well as support the Business through strong cross-functional collaboration.
 
 
 
 
 
 
 Your Responsibilities will be:
 
 
 
 
 
 <ul>
 <li>
 Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.
 </li>
 <li>
 Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
 </li>
 <li>
 Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).
 </li>
 <li>
 Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
 </li>
 <li>
 Responsible of ordering and legalization of local CPP and other module 1 documents for local products.
 </li>
 <li>
 Perform regulatory due diligence on module 1 for all assigned products for the Gulf according to internal process/guidance according to EU/local Region regulatory requirements.
 </li>
 <li>
 Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
 </li>
 <li>
 Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
 </li>
 <li>
 Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
 </li>
 <li>
 Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
 </li>
 <li>
 Maintain the Regulatory databases: drug track and docubridge for local products.
 </li>
 <li>
 Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
 </li>
 <li>
 Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
 </li>
 <li>
 All trainings to be completed as per training plan.
 </li>
 </ul>
 
 
 
 
 
 Your Profile:
 
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy or a relevant field.
 </li>
 <li>
 0 &ndash; 3 years of experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
 </li>
 <li>
 Fluent level in English and Arabic both in oral and written communication.
 </li>
 </ul>
 
 
 
 
 This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
 
</div>

Regulatory Affairs Associate, GULF

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