associate regulatory affairs - based in egypt

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associate regulatory affairs - based in egypt Jobs in Cairo

associate | regulatory | qrs | egypt Jobs in Cairo

associate | regulatory | qrs | egypt

regulatory affairs officer

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

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

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)

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>
 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

dLocal

<div>
 
 What&rsquo;s the opportunity?
 
 
 
 As our Regulatory and Licensing Officer based in with the MENA region, you will support all Compliance and Regulatory matters related to Dlocal&rsquo;s business and operation and will help maintain oversight for Dlocal&rsquo;s legal entities. In this role, you will help enable business growth while serving as a gatekeeper to prevent regulatory, legal, and reputational harm.
 
 
 
 What will I be doing?
 
 
 
 <ul>
 <li>
 Provides legal knowledge and expertise on financial, payments, and fintech regulations in MENA countries
 </li>
 <li>
 Provide effective advice to all the internal teams to find solutions and identify potential risks on implementing the regulatory requirements for Dlocal's entities, advising in any regulatory impact from the initial stage to the end, enabling the business to scale and grow
 </li>
 <li>
 Advice relevant stakeholders in identifying laws and regulations that could impact to the company, training on material and method to be used, assessing training competence, and monitoring adherence to and compliance with training plans
 </li>
 <li>
 Advise line management on possible legal and regulatory impact across all divisions of regulatory developments and trends while highlighting potential revenue generation/cost-saving opportunities
 </li>
 <li>
 Liaising with relevant stakeholders across Dlocal&acute;s business divisions to drive compliance with identified regulatory and statutory requirements and obligations
 </li>
 <li>
 Supporting activities to create company-wide awareness of regulatory and statutory requirements and the importance of complying with these requirements
 </li>
 <li>
 Contribute to drafting company policies and internal processes
 </li>
 <li>
 Maintaining a compliance calendar and submitting legal and regulatory returns when due, in collaboration with the respective teams
 </li>
 <li>
 Assess and continuously advise the respective departments on AML &amp; CFT, Data Privacy, and fintech regulations
 
 
 
 </li>
 </ul>
 
 What skills do I need?
 
 
 
 <ul>
 <li>
 Advanced degree in (preferably) law, compliance, finance, or a comparable study
 </li>
 <li>
 5+ years experience in a regulatory or compliance officer role or legal advisor
 </li>
 <li>
 You are fluent in English and Arabic (written and spoken) is mandatory
 </li>
 <li>
 Experience gained in an international company, Payments, financial institution, or law firm is a must
 </li>
 <li>
 Highly analytical with strong attention to detail
 </li>
 <li>
 Professional, flexible, and highly responsible and hands-on
 
 
 
 </li>
 </ul>
 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
</div>

Regulatory and Licensing Officer - MENA

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