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manager of regulatory affairs

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

Delta Pharma

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

Regulatory Affairs Section Head

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

Regulatory Affairs Manager

Amgen

<div>
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 <ul>
 <li>
 If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
 
 
 </li>
 </ul>
 Job purpose:
 
 
 <ul>
 <li>
 As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
 
 
 </li>
 </ul>
 Job Responsibilities:
 
 
 <ul>
 <li>
 Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
 </li>
 <li>
 Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate
 </li>
 <li>
 Participate in local regulatory process improvements initiatives
 </li>
 <li>
 Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
 </li>
 <li>
 Ensure delivery of right first time label source text for artwork creation
 </li>
 <li>
 Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
 </li>
 <li>
 Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
 </li>
 <li>
 Access the translation agency systems to request the label translation and track the job readiness and timelines.
 </li>
 <li>
 Perform regional prescribing information translation review: 100% review of both content and format
 </li>
 <li>
 Perform the role of source text owner/approver and artwork reviewer/approver in the system
 </li>
 <li>
 Trigger the existing label revision when alerted by global RA team.
 </li>
 <li>
 Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
 </li>
 <li>
 Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
 
 </li>
 </ul>
 Qualifications:
 
 
 <ul>
 <li>
 Experience +2 years in Regulatory Affairs
 </li>
 <li>
 Current/ previous experience in working as part of an MNC employer
 </li>
 <li>
 Pharmacist, biologist, chemist-medical background
 </li>
 <li>
 Fluent in English and Arabic for translation review purpose ( French is a huge plus)
 </li>
 <li>
 A minimum knowledge of Middle East Africa regulatory requirements
 </li>
 <li>
 Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
 </li>
 <li>
 Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.
 
 
 </li>
 </ul>
 What You Can Expect Of Us
 
 
 As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 <ul>
 <li>
 Vast opportunities to learn and move up and across our global organization
 </li>
 <li>
 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
 </li>
 <li>
 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
 </li>
 </ul>
 Apply now for a career that defies imagination
 
 
 In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
 
 
 careers.amgen.com
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
 
 
 We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
</div>

MEA Regulatory Affairs Senior Associate

Deloitte

<div>
 
 About Deloitte
 
 : When you work for us, you commit to a career at one of the largest and most prestigious professional services firms in the world. We have received numerous awards over the last few years, including Best Employer in the Middle East, and Best Consulting Firm, and the Middle East Training &amp; Development Excellence Award.
 
 
 
 Our Purpose
 
 
 
 Deloitte makes an impact that matters. Every day we challenge ourselves to do what matters most&mdash;for clients, for our people, and for society. We serve clients distinctively, bringing innovative insights, solving complex challenges and unlocking sustainable growth. We inspire our talented professionals to deliver outstanding value to clients, providing an exceptional career experience and an inclusive and collaborative culture. We contribute to society, building confidence and trust in the markets, upholding the integrity of organizations and supporting our communities.
 
 
 Our shared values guide the way we behave to make a positive, enduring impact:
 
 
 <ul>
 <li>
 Lead the way
 </li>
 <li>
 Serve with integrity
 </li>
 <li>
 Take care of each other
 </li>
 <li>
 Foster inclusion
 </li>
 <li>
 Collaborate for measurable impact
 
 
 </li>
 </ul>
 During your tenure as Associate &ndash; Regulatory specialist, you will demonstrate and develop your capabilities in the following areas:
 
 
 <ul>
 <li>
 Collect data and reports from the various regulatory partners.
 </li>
 <li>
 Support the regulatory leader with the day-to-day tasks.
 </li>
 <li>
 Perform risk assessments.
 </li>
 <li>
 Establish a process to periodically reassess risks and emerging issues.
 </li>
 <li>
 Perform risk evaluation and mitigation methodologies.
 </li>
 <li>
 Maintain risk registers.
 </li>
 <li>
 Completion and submission of Reports.
 </li>
 <li>
 Stakeholder Management.
 </li>
 <li>
 Assist in framework implementation.
 </li>
 <li>
 Address questions of colleagues in relation to regulatory matters in a timely manner.
 </li>
 <li>
 Arrange meetings and minutes.
 
 
 </li>
 </ul>
 
 Leadership Capabilities
 
 
 
 <ul>
 <li>
 Builds own understanding of our purpose and values; explores opportunities for impact.
 </li>
 <li>
 Demonstrates strong commitment to personal learning and development; acts as a brand ambassador to help attract top talent
 </li>
 <li>
 Understands expectations and demonstrates personal accountability for keeping performance on track
 </li>
 <li>
 Actively focuses on developing effective communication and relationship-building skills
 </li>
 <li>
 Understands how their daily work contributes to the priorities of the team and the business.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Degree from a reputable University in Risk Management, Accounting, Finance, Business Administration, Commercial Law, or a related field.
 </li>
 <li>
 0 to 2 years of experience.
 </li>
 <li>
 Strong knowledge of risks&rsquo; identification, assessment, and management frameworks.
 </li>
 <li>
 Strong knowledge of control frameworks, and the ability to design and evaluate effectiveness of controls embedded within business processes.
 </li>
 <li>
 Communication and data visualization skills.
 </li>
 <li>
 High analytical skills with strong attention to detail.
 </li>
 <li>
 Strong computer literacy, including Microsoft Word, Excel, PowerPoint.
 </li>
 <li>
 Strong presentation skills.
 </li>
 <li>
 Excellent organizational and planning skills.
 </li>
 <li>
 Ability to understand broader business issues.
 </li>
 <li>
 Excellent command of the English language, both verbal and written.
 </li>
 <li>
 Certification in Governance, Risk and Compliance will be considered an advantage.
 </li>
 <li>
 Fluent in Arabic and English languages.
 </li>
 </ul>
</div>

Associate | Regulatory | QRS | Egypt

Kraft Heinz

<div>
 The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
 </li>
 <li>
 Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
 </li>
 <li>
 Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
 </li>
 <li>
 Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
 </li>
 <li>
 Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
 </li>
 <li>
 Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
 </li>
 <li>
 Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
 </li>
 <li>
 Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
 </li>
 <li>
 Proactively identify and communicate SRA risk in any project or work stream
 </li>
 <li>
 Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
 </li>
 <li>
 Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
 </li>
 <li>
 Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
 </li>
 <li>
 Provide technical and legal labelling Information and support artwork approval process
 </li>
 <li>
 Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
 </li>
 <li>
 Scientific and regulatory affairs representation in all projects driven forums
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
 </li>
 <li>
 5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
 </li>
 <li>
 Experience working with Microsoft programs and system tools related to recipes and artworks
 </li>
 <li>
 Experience in translation is preferred
 </li>
 <li>
 Fluent in Arabic &amp; English, French is a plus
 </li>
 </ul>
</div>

Scientific & Regulatory Affairs Specialist – Africa & Trading

Sandoz Egypt

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

Regulatory Affairs Artwork Associate

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