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regulatory affairs sr specialist nemag

AstraZeneca

<div>
 
 
 Play a key role in bringing innovative medicines to patients. Join AstraZeneca&rsquo;s Regulatory Affairs team and help navigate the regulatory pathway that supports the development, approval, and lifecycle management of impactful therapies.
 
 
 
 
 
 About Astrazeneca
 
 
 
 AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world&rsquo;s most serious diseases. But we&rsquo;re more than one of the world&rsquo;s leading pharmaceutical companies.
 
 
 Join a high-performing team, empowered to cut through the noise and drive real change. Our agility and pace, coupled with scientific focus, powers us to spot opportunities in the market that keep us moving forward and into new spaces.
 
 
 
 Why AstraZeneca?
 
 
 
 At AstraZeneca we&rsquo;re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There&rsquo;s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We&rsquo;re on an exciting journey to pioneer the future of healthcare.
 
 
 
 About The Role
 
 
 
 
 Job Purpose:
 
 
 
 As a Regulatory Affairs Senior Specialist, you will be responsible for supporting the development and execution of global regulatory strategies to ensure timely approval and lifecycle management of AstraZeneca&rsquo;s products. This role collaborates cross-functionally with clinical, medical, and commercial teams to ensure regulatory compliance while enabling efficient delivery of innovative medicines to patients.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Support the preparation and submission of regulatory dossiers to the health authorities.
 </li>
 <li>
 Contribute to the development and implementation of regulatory strategies across product registrations &amp; lifecycles for NEMAG markets mainly Iraq &amp; Palestine.
 </li>
 <li>
 Ensure regulatory submissions comply with regional and international guidelines and standards.
 </li>
 <li>
 Coordinate with cross-functional teams including clinical development, safety, and quality.
 </li>
 <li>
 Maintain accurate regulatory documentation and submission records.
 </li>
 <li>
 Track regulatory commitments and support responses to health authority queries.
 </li>
 <li>
 Monitor evolving regulatory requirements and communicate potential impacts to stakeholders.
 </li>
 <li>
 Assist with new products &amp; manufacturing sites registration &amp; lifecycle management activities including variations, renewals &amp; label updates.
 </li>
 <li>
 Support preparation for regulatory meetings and health authority interactions.
 </li>
 <li>
 Contribute to continuous improvement initiatives within the Regulatory Affairs function.
 
 
 </li>
 </ul>
 
 Job Requirements
 
 
 
 
 Essential Criteria:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy or any other scientific discipline.
 </li>
 <li>
 A minimum of 3 years of experience in Regulatory Affairs in a multinational pharmaceutical company.
 </li>
 <li>
 Proficiency in Arabic and English language is a must.
 </li>
 <li>
 Strong communication, presentation, and negotiation, with the ability to convey complex information clearly and inspire cross-functional collaboration.
 </li>
 <li>
 Proficiency in Microsoft Office.
 </li>
 <li>
 Regulatory fundamentals knowledge.
 </li>
 <li>
 Flexible for travel upon business need.
 
 
 </li>
 </ul>
 
 Preferred Criteria
 
 
 
 <ul>
 <li>
 Regional Regulatory Affairs experience (mainly Iraq).
 </li>
 <li>
 Vault System knowledge.
 
 
 </li>
 </ul>
 
 
 Please note that this position is based in Cairo and is not open for relocation; only apply if you are located in or can easily access this location.
 
 
 
 
 
 Where can I find out more?
 
 
 
 Our Social Media,
 
 
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 
 
 Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
 
 
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
 
 
 
 Date Posted
 
 
 
 09-Mar-2026
 
 
 
 Closing Date
 
 
 
 15-Mar-2026
 
 
 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
</div>

Regulatory Affairs Sr. Specialist - NEMAG

Jamjoom Pharma

<div>
 
 Role Overview
 
 
 
 We are seeking a detail-oriented and proactive
 
 Export Regulatory Affairs Specialist
 
 with mandatory fluency in French and English to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.
 </li>
 <li>
 Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.
 </li>
 <li>
 Ensure compliance with export regulations, customs requirements, and country-specific guidelines.
 </li>
 <li>
 Liaise with agents, distributors, and internal teams to resolve regulatory queries.
 </li>
 <li>
 Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.
 </li>
 <li>
 Support audits, inspections from export countries.
 </li>
 <li>
 Develop and optimize workflows for regulatory submissions and export documentation.
 
 
 </li>
 </ul>
 
 Qualifications &amp; Requirements
 
 
 
 
 Education
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Life Sciences, or a related field (mandatory).
 </li>
 <li>
 Additional training or certification in Regulatory Affairs is considered a plus.
 
 
 </li>
 </ul>
 
 Experience
 
 
 
 <ul>
 <li>
 3&ndash;5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on export submissions.
 </li>
 <li>
 Proven experience in CTD/eCTD dossier preparation, publishing, and submission for international markets.
 </li>
 <li>
 Solid knowledge of international regulatory requirements and export-related guidelines.
 </li>
 <li>
 Experience working with agents and distributors across multiple countries is an advantage.
 </li>
 <li>
 Fluency in French is a must (written and spoken).
 </li>
 <li>
 Fluency in English (written and spoken)
 
 
 </li>
 </ul>
 
 Skills &amp; Competencies
 
 
 
 <ul>
 <li>
 Regulatory Expertise: Strong understanding of global regulatory frameworks and export compliance requirements.
 </li>
 <li>
 Technical Writing: Excellent ability to prepare clear, accurate, and compliant regulatory documentation.
 </li>
 <li>
 Communication: Fluent in English (written and spoken); French language skills are required.
 </li>
 <li>
 Organization &amp; Attention to Detail: High level of accuracy in managing multiple dossiers and regulatory documents.
 </li>
 <li>
 Cross-functional Collaboration: Ability to work effectively with internal teams and external partners.
 </li>
 <li>
 Systems &amp; Tools: Proficient in documentation management systems and MS Office applications.
 </li>
 <li>
 Problem Solving: Proactive in identifying issues and driving timely regulatory solutions.
 </li>
 <li>
 Integrity &amp; Compliance: Demonstrates strong ethical standards and commitment to regulatory compliance.
 </li>
 </ul>
</div>

Export Regulatory Affairs specialist (French)

Grifols Egypt for Plasma Derivatives (GEPD)

<div>
 
 Job Objective:
 
 
 
 Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).
 
 
 Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).
 
 
 
 Key responsibility:
 
 
 
 <ul>
 <li>
 Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
 </li>
 <li>
 Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
 </li>
 <li>
 Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
 </li>
 <li>
 Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
 </li>
 <li>
 Change notification to Local and International Health Authorities.
 </li>
 <li>
 Change notification and customers related to Change Control implementation.
 </li>
 <li>
 To assist Direct Manager in any assigned duties.
 </li>
 <li>
 Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
 </li>
 <li>
 Post-Graduate Certification in Quality Management.
 </li>
 <li>
 Knowledge of cGMP requirements preferred.
 </li>
 <li>
 Minimum of 4 years of Management or technical leadership experience is required.
 </li>
 <li>
 Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
 </li>
 <li>
 Manufacturing background, and Final Product importation and exportation experience.
 </li>
 <li>
 Preferably with experience on EMA Regulatory requirements and submissions.
 
 </li>
 </ul>
</div>

Regulatory Affairs Sr. Manager

<div>
 
 Job Title
 
 Regulatory Assistant
 
 
 
 Designation
 
 Regulatory Assistant (Crop Protection&amp; Natural Plant Protection (NPP))
 
 
 
 Reporting To
 
 Head of Regulatory, Egypt &amp; Sudan
 
 
 
 Skip Level Reporting
 
 Regulatory Head, Africa
 
 
 
 Function
 
 Regulatory
 
 
 
 GJL
 
 GJL 2B
 
 
 
 Location
 
 Egypt/Sudan
 
 
 
 About Upl
 
 
 
 UPL is focused on emerging as a premier global provider of total crop solutions designed to secure the world&rsquo;s long-term food supply. Winning farmer's hearts across the globe, while leading the way with innovative products and services that make agriculture sustainable, UPL is the fastest-growing company in the industry. Our successes in the field add up to powerful financials. UPL delivers results from protecting crops that translate into attractive investor value. Based on the recognition that humankind is one community, UPL&rsquo;s overarching commitment is to improve areas of its presence, workplace, and customer engagement.
 
 
 Our purpose is &lsquo;OpenAg&rsquo;. An agriculture network that feeds sustainable growth for all. No limits, no borders.
 
 
 We are one team, for maximum impact. One team with shared goals. We have a laser-like focus on what our customers need and want, on anticipating their future needs, and on how we can create innovative solutions and experiences for them. We think outside the box and go beyond our comfort zone. We believe in agility, we mix the power of speed, with structure from process. And wherever we can, we always believe in having fun
 
 
 Role Summary
 
 
 Manage routine activities, including but not limited to, studying and compiling scientific and legal documents to ensure that all products are following governmental regulations. Work in partnership with the Regulatory Affairs Manager to ensure that all regulatory requirements are fully achieved with submission timelines and forecasted regulatory project budgets.
 
 
 Role Responsibilities
 
 
 
 Regulatory
 
 
 
 <ul>
 <li>
 Follow up all regulatory matters with APC, CAPL, Fertilizer committee and all other official entities.
 </li>
 <li>
 Ensure the Registration Certificates and Labels are valid for all products through continuous follow-up with the Regulatory Affairs Manager and relevant authorities.
 </li>
 <li>
 Prepare and submit periodic status reports on products, registrations, and ongoing regulatory projects.
 </li>
 <li>
 Draft and prepare official correspondence and letters required by various regulatory authorities.
 </li>
 <li>
 Maintain regular communication with officials and act as a primary liaison between the Regulatory Manager and regulatory authorities.
 </li>
 <li>
 Ensure that all regulatory project expenses are paid in full and on time, in close coordination with the Regulatory Manager.
 </li>
 <li>
 Follow up all activities relevant to the Official Trial Program (OTP).
 </li>
 <li>
 Keep good relationship with all regulatory bodies and the authorities.
 </li>
 <li>
 Keeping all databases and information up to date in all regulatory systems.
 </li>
 <li>
 Ensure full compliance with company policies and local regulatory requirements.
 
 
 </li>
 </ul>
 
 Responsibility Weightage and % of Time Spent Matrix
 
 
 
 Responsibility
 
 
 Weightage
 
 
 % of Time Spent
 
 
 Regulatory
 
 
 100
 
 
 100%
 
 
 External Interactions
 
 
 
 Regulatory Authority:
 
 Maintain high quality interactions and professional relationships with registrar's office is of paramount important to business.
 
 
 <ul>
 <li>
 Clarification of registration requirements.
 </li>
 <li>
 Resolving queries on existing registrations as well as for new submissions.
 </li>
 <li>
 Follow-up on projects submitted within portfolio.
 
 
 </li>
 </ul>
 
 Knowledge, Skills And Experience Required
 
 
 
 
 Technical Requirements:
 
 
 
 <ul>
 <li>
 At least one to two years of experience in regulatory affairs and procedures.
 </li>
 <li>
 Minimum of B.Sc but preferably a post-graduate qualification (Hons. or M.Sc.) in Crop. Agriculture, Plant Pathology, Pesticides or Microbiology.
 </li>
 <li>
 English, Arabic: Fluent (Spoken &ndash; Written).
 </li>
 <li>
 Microsoft Office application and Internet surfing and Internet surfing.
 </li>
 <li>
 Technical knowledge of pesticides, fertilizers, and agricultural sciences.
 
 
 </li>
 </ul>
 
 Behavioural Requirements
 
 
 
 <ul>
 <li>
 Detail orientated and analytical is key to meet the high level of accuracy required for regulatory compliance. Working in a solution driven environment requires a self-motivated and persistent individual with a high level of creativity to work towards fact-based problem solving. Good sense of time-management and prioritization skills to support diverse projects running in parallel. Integrity and a professional approach to work.
 
 
 </li>
 </ul>
 UPL Competencies
 
 
 <ul>
 <li>
 Adaptability &amp; Resilience
 
 
 </li>
 </ul>
 Recognizes and is open to changing circumstances and alters behavior and scales up as necessary; increases personal awareness and appreciation of individual and cultural differences to create an open, inclusive, and accepting workplace
 
 
 <ul>
 <li>
 Entrepreneurial Mindset
 
 
 </li>
 </ul>
 Has a creative mindset and ability to think holistically, takes calculated risks and maximizes opportunities
 
 
 <ul>
 <li>
 Results Orientations
 
 
 </li>
 </ul>
 Acts, pursues goals with persistence and achieves results; communicates goals and vision to the team to drive enthusiasm and ambition
 
 
 <ul>
 <li>
 Execution Excellence
 
 
 </li>
 </ul>
 Enhances the speed of execution and builds efficiency in processes, systems, and people; has sharp focus on quality-orientation
 
 
 <ul>
 <li>
 Strategic Orientation
 
 
 </li>
 </ul>
 Demonstrates knowledge of the social, economic, and environmental factors and how they impact business. Identifies key issues that could impact the business and develops strategy through an analytical lens / design thinking
 
 
 <ul>
 <li>
 Building Teams and Talent
 
 
 </li>
 </ul>
 Empowers colleagues through knowledge sharing and delegation, quickly establishing rapport; provides recognition for achievements and accomplishments
</div>

Regulatory Assistant (Crop Protection& Natural Plant Protection (NPP))

<div>
 <ul>
 <li>
 Support the implementation of the Compliance Program across all departments, ensuring alignment with corporate and global compliance standards.
 </li>
 <li>
 Assist in conducting risk assessments, monitoring activities, and compliance audits, and follow up on corrective and preventive actions (CAPAs).
 </li>
 <li>
 Facilitates the management of Third Party interacting on behalf of GEPD, coordinating background checks on vendors, preparing comprehensive reports in accordance with due diligence processes.
 </li>
 <li>
 Maintain and update compliance-related documentation, including SOPs, training records, and assurance reports.
 </li>
 <li>
 Coordinate training sessions to promote awareness of ethics, compliance policies.
 </li>
 <li>
 Monitor and report on compliance metrics, highlighting potential gaps or process deviations.
 </li>
 <li>
 Liaise with internal stakeholders (Commercial, HR, Medical Affairs, etc.) to ensure smooth execution of compliance requirements.
 </li>
 <li>
 Provide assistance in preparing for inspections and audits, ensuring readiness and proper documentation.
 </li>
 <li>
 Participate in investigations and documentation of non-compliance events, ensuring corrective actions are tracked and closed.
 </li>
 <li>
 Promote a culture of ethics, integrity, inclusion, and transparency in all business activities.
 </li>
 <li>
 Serve as a point of contact for employees seeking clarification on compliance procedures or reporting obligations.
 </li>
 </ul>
 
 
 Academic &amp; Professional experience required
 
 
 <ul>
 <li>
 Bachelors degree in Pharmacy, Law, Business Administration, or a related discipline.
 </li>
 <li>
 7 plus years of experience in a control function e.g. Medical affairs, Quality, or Regulatory affairs (preferably in the pharmaceutical or healthcare sector), at least 2&ndash;4 years of which is in compliance.
 </li>
 <li>
 Strong understanding of compliance frameworks, SOP management, and audit processes
 </li>
 <li>
 Proficient in Microsoft Office and reporting tools.
 </li>
 <li>
 Very Good English
 </li>
 </ul>
</div>

Corporate Compliance Lead

<div>
 <ul>
 <li>
 Support the implementation of the Compliance Program across all departments, ensuring alignment with corporate and global compliance standards.
 </li>
 <li>
 Assist in conducting risk assessments, monitoring activities, and compliance audits, and follow up on corrective and preventive actions (CAPAs).
 </li>
 <li>
 Facilitates the management of Third Party interacting on behalf of GEPD, coordinating background checks on vendors, preparing comprehensive reports in accordance with due diligence processes.
 </li>
 <li>
 Maintain and update compliance-related documentation, including SOPs, training records, and assurance reports.
 </li>
 <li>
 Coordinate training sessions to promote awareness of ethics, compliance policies.
 </li>
 <li>
 Monitor and report on compliance metrics, highlighting potential gaps or process deviations.
 </li>
 <li>
 Liaise with internal stakeholders (Commercial, HR, Medical Affairs, etc.) to ensure smooth execution of compliance requirements.
 </li>
 <li>
 Provide assistance in preparing for inspections and audits, ensuring readiness and proper documentation.
 </li>
 <li>
 Participate in investigations and documentation of non-compliance events, ensuring corrective actions are tracked and closed.
 </li>
 <li>
 Promote a culture of ethics, integrity, inclusion, and transparency in all business activities.
 </li>
 <li>
 Serve as a point of contact for employees seeking clarification on compliance procedures or reporting obligations.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelors degree in Pharmacy, Law, Business Administration, or a related discipline.
 </li>
 <li>
 7 plus years of experience in a control function e.g. Medical affairs, Quality, or Regulatory affairs (preferably in the pharmaceutical or healthcare sector), at least 2&ndash;4 years of which is in compliance.
 </li>
 <li>
 Strong understanding of compliance frameworks, SOP management, and audit processes
 </li>
 <li>
 Proficient in Microsoft Office and reporting tools.
 </li>
 <li>
 Very Good English
 
 </li>
 </ul>
</div>

Diversey

<div>
 
 
 Job Title:
 
 Product Registration Lead &ndash; MENA
 
 Location:
 
 Cairo, Egypt
 
 
 
 
 
 
 Job Summary:
 
 Designs, develops, implements and oversees the organization's environmental, health and safety programs and procedures to safeguard employees and surrounding communities, and ensures all facilities and products are in compliance with local and regional regulations across the MENA region.
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Lead the registration and re-registration of products (hygiene &amp; cleaning solutions) across MENA markets in compliance with local regulatory requirements
 </li>
 <li>
 Liaise with government authorities and regulatory bodies in Egypt and across the region to obtain and maintain product approvals
 </li>
 <li>
 Ensure all products meet EHS standards and local safety regulations before market launch
 </li>
 <li>
 Maintain and update regulatory documentation, SDS (Safety Data Sheets), and product dossiers
 </li>
 <li>
 Monitor changes in MENA regulations and communicate updates to relevant internal teams
 </li>
 <li>
 Collaborate cross-functionally with R&amp;D, Supply Chain, Marketing, and Commercial teams to support new product launches
 </li>
 <li>
 Support EHS compliance programs and ensure alignment with global Solenis/Diversey policies
 </li>
 <li>
 Manage product labeling requirements per country-specific regulations
 </li>
 </ul>
 
 
 Qualifications:
 
 
 <ul>
 <li>
 Bachelor's degree in Chemistry, Chemical Engineering, Environmental Science, or related field
 </li>
 <li>
 5+ years of experience in regulatory affairs or product registration, preferably in hygiene, chemicals, or FMCG
 </li>
 <li>
 Strong knowledge of MENA regulatory landscape
 </li>
 <li>
 Fluent in Arabic and English
 </li>
 <li>
 Strong organizational and project management skills
 </li>
 <li>
 Preferrable to have an experience with the Egyptian Drug Authority (EDA)
 </li>
 </ul>
</div>

Product Registration Lead – MENA

Explore 182+ Regulatory affairs sr specialist nemag in Cairo this March. Find roles across top companies and apply now to boost your career.

182 regulatory affairs sr specialist nemag jobs In Cairo

Regulatory Affairs Sr. Specialist - NEMAG

Export Regulatory Affairs specialist (French)

Regulatory Affairs Sr. Manager

Regulatory Assistant (Crop Protection& Natural Plant Protection (NPP))

Corporate Compliance Lead

Corporate Compliance Lead

Product Registration Lead – MENA