senior regulatory affairs specialist

IQVIA

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

Senior Regulatory Affairs Specialist

Imdad

<div>Regulatory Affairs Senior Specialist acts as the liaison between the company and regulatory authorities (SFDA) to ensure that imported products are manufactured and distributed in compliance with appropriate governmental legislation.
Job Responsibilities
I. Regulatory Affairs:<ul><li>
Act as one of the main points of contact for SFDA and be responsible for Imdad&rsquo;s products.</li><li>
Report the status of the products and related tasks on a monthly basis.</li><li>
Ensure that the equipment is in compliance with SFDA regulations.</li><li>
Follow up with logistics for the importation of Imdad&rsquo;s products including Equipment, Accessories and cosmetics.</li><li>
Obtain Faseh &amp; Nnjzha approval for logistics to ensure compliant importation of products.</li><li>
Ensure approval of product registration applications for equipment, cosmetics, and accessories in KSA.</li><li>
Ensure the update of registrations in accordance with relevant legislation, regulations, and guidelines.</li><li>
Prepare complete registration dossiers for all products, including reviewing and verifying their compliance with SFDA requirements and regulations.</li><li>
Coordinate with suppliers regarding equipment specifications and documentation.</li><li>
Review and validate all documents before submission to SFDA.
</li><li>Track and ensure that applicable fees are paid on time and all licenses are renewed in a timely manner.</li><li>
Support other internal departments with regulatory requests and complaints.
</li><li>Monitor updates to SFDA regulations, guidelines, and circulars, assess their impact on company products, and ensure timely implementation of required changes.</li></ul>
II. Quality Assurance:<ul><li>
Ensure that the QMS processes are established, implemented, and maintained.</li><li>
Report to the direct manager on how well or poorly the QMS is performing.</li><li>
Regularly review the QMS objectives.</li><li>
Maintain appropriate records.</li><li>
Ensure that all Good Distribution and Storage Practices are applied.</li></ul> 

Requirements 
 
Minimum Qualifications<ul><li>
Bachelor&rsquo;s degree in biomedical engineering or any related Medical Scientific Field
</li><li>Minimum 2 years of experience in Regulatory Affairs</li></ul> 
Required Skills<ul><li>
Excellent communication skills (oral &amp; written), and ability to work well in a team.</li><li>
Time Management skills.</li><li>
Good computer skills (MS. Office, Excel &amp; Outlook)</li><li>
Good knowledge on SFDA Platforms ( Ghad, NnJzha, Faseh ).</li><li>
Excellent organization skills.</li><li>
Excellent Arabic and English skills (Written &amp; spoken).</li></ul></div>

Regulatory Affairs & Quality Assurance Senior Specialist - Riyadh

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)

POS Enterprise

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

Regulatory Affairs Specialist

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Riyadh, Saudi Arabia
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for Regulatory Affairs Specialist.
Purpose:
The main task of a Regulatory Affairs specialist in Johnson &amp; Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration &amp; importation guidance.
You will be responsible for:<ul><li>
Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&amp;J distributors when applicable</li><li>
SFDA meetings.</li><li>
Clearance support to distributers.</li><li>
Updating the regulatory tracking systems</li><li>
Having the renewed certificates &amp; re-registration licenses of expired ones on time.</li><li>
Responding to Change Impact Assessments before due dates.</li><li>
Doing Copy Review process for promotional materials on time upon request.</li><li>
Lift all regulatory restrictions for products that can be shipped to Saudi Arabia</li><li>
Tender support to commercial teams &amp; distributers</li></ul>
Qualifications / Requirements:<ul><li>
Education: Bachelor&rsquo;s (B.Sc.) Degree of Biomedical engineering or Sciences</li><li>
Experience; min. 2 years</li><li>
Language: English - Arabic 
</li></ul>Key Competencies:<ul><li>
Time Management</li><li>
Presentation &amp; Communication Skills</li><li>
Involvement in Regional Projects.</li></ul>
Required Skills:
Preferred Skills:
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented</div>

Regulatory Affairs Specialist | Johnson & Johnson MedTech | Riyadh - KSA

Stellar Hunters

<div><h4 class="jobSectionHeader">Job Summary</h4>
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.<h4 class="jobSectionHeader">
Key Responsibilities</h4><h5 class="jobSectionHeader">
Regulatory Submissions &amp; Approvals</h5><ul><li>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</li><li>
Track and manage product registration timelines, renewals, and approvals.</li></ul><h5 class="jobSectionHeader">
Compliance &amp; Documentation</h5><ul><li>
Ensure all products and processes comply with local and international regulatory requirements.</li><li>
Maintain up-to-date regulatory documentation, technical files, and records.</li></ul><h5 class="jobSectionHeader">
Regulatory Intelligence</h5><ul><li>
Monitor changes in regulations and guidelines and assess their impact on the business.</li><li>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</li></ul><h5 class="jobSectionHeader">
Cross-functional Collaboration</h5><ul><li>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</li><li>
Support new product development by providing regulatory guidance and requirements.</li></ul><h5 class="jobSectionHeader">
Audit &amp; Inspection Support</h5><ul><li>
Support internal and external audits, inspections, and regulatory inquiries.</li><li>
Ensure readiness and proper documentation for compliance reviews.</li></ul><h5 class="jobSectionHeader">
Labeling &amp; Claims Review</h5><ul><li>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</li><li>
Ensure all product claims are supported and aligned with regulatory standards.</li></ul><h5 class="jobSectionHeader">
Continuous Improvement</h5><ul><li>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</li></ul><h4 class="jobSectionHeader">
Required Qualifications - Skills &amp; Experience</h4><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</li><li>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</li><li>
Strong knowledge of regulatory frameworks and submission processes.</li><li>
Experience with product registration and regulatory documentation.</li><li>
Excellent attention to detail and organizational skills.</li><li>
Strong communication and stakeholder management skills.</li></ul><h4 class="jobSectionHeader">
Preferred Qualifications</h4><ul><li>
Experience with Saudi regulatory bodies such as SFDA.</li><li>
Familiarity with GCC or international regulatory requirements.</li><li>
Experience with electronic submission systems and regulatory databases.</li><li>
Certification or training in regulatory affairs is a plus.</li></ul><h4 class="jobSectionHeader">
Work Environment &amp; Compensation</h4><ul><li>
Full-time position with an onsite model.</li><li>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</li><li>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</li><li>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</li></ul></div>

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>

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