regulatory affairs specialist

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>

Regulatory Affairs Specialist

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>

<div>Site Name: Saudi Arabia - Riyadh 
Posted Date: Apr 8 2026 
GSK Saudi Arabia is committed to supporting Vision 2030 and the Saudi Arabian National Agenda including Saudization in line with the hiring and the training and development of Saudi National capability.
Role overview 
We are seeking a Regulatory Affairs Officer to support SFDA submissions, lifecycle management, labelling and cross‑functional regulatory activities for locally marketed and globally supplied products. This is an in‑office role based in Riyadh and involves close coordination with global RA teams, local site QA/RA contacts, commercial, medical, supply and external partners.
Key responsibilities<ul><li>
Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies</li><li>
Maintain product licenses and manage timelines for renewals, changes and variations</li><li>
Coordinate and review regulatory labelling and packaging (including Arabic translations) to ensure SFDA compliance</li><li>
Support regulatory projects and liaise with global and local stakeholders to deliver required RA activities</li><li>
Coordinate locally manufactured product changes with site RA and quality teams</li><li>
Monitor SFDA and regional regulatory updates; assess impact and communicate to stakeholders</li><li>
Serve as primary RA contact for internal teams and external agents/distributors; represent GSK in regulatory meetings as needed</li><li>
Maintain regulatory tracking dashboards and audit‑ready documentation, support health authority inspections</li><li>
Communicate with SFDA via approved channels and arrange meetings with relevant SFDA departments when necessary</li><li>
Provide cross‑functional regulatory support for tender submissions, promotional material approvals and product supply strategy</li></ul>
Essential qualifications &amp; experience<ul><li>
Bachelor&rsquo;s degree in pharmacy, Pharmaceutical Sciences or related life sciences field</li><li>
1&ndash;3 years&rsquo; Regulatory Affairs experience in a multinational pharmaceutical company, with strong exposure to SFDA submissions and Saudi market requirements</li><li>
Fluent in Arabic and English (written and spoken)</li><li>
Deep understanding of SFDA regulations, eCTD requirements, labelling standards and regulatory lifecycle management</li><li>
Strong organizational, project coordination and communication skills; ability to manage multiple priorities under tight timelines</li><li>
Demonstrated experience implementing regulatory change and SOPs consistent with global/local RA frameworks</li><li>
Strong stakeholder engagement and negotiation skills</li></ul>
Mandatory<ul><li>
Saudi national</li><li>
Saudi‑licensed pharmacist</li></ul>
Nice to have<ul><li>
Exposure to price negotiation or pricing appeals with SFDA</li><li>
Experience liaising with scientific office or providing pharmacovigilance oversight</li></ul>
Work Environment 
This role is based in Riyadh, Saudi Arabia.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Why GSK? 
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information: 
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</div>

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)

<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.
 
 
 
 Job Summary
 
 
 
 We are seeking a detail-oriented and driven
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The&nbsp;ideal candidate will contribute to our mission of enhancing human health and well-being,&nbsp;ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Prepare and submit regulatory applications and documentation to the appropriate authorities within Europe
 </li>
 <li>
 Review and assess product labeling, promotional materials, and technical documentation for compliance with regulatory requirements
 </li>
 <li>
 Maintain knowledge of current and evolving regulations in the pharmaceutical sector, particularly within the European Union
 </li>
 <li>
 Act as the liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or issues
 </li>
 <li>
 Support the development of regulatory strategies for new product registrations and life cycle management
 </li>
 
 
 </ul>
 
 Requirements
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy, Life Sciences, or a related field
 </li>
 <li>
 1-3 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
 </li>
 <li>
 Knowledge of EU regulatory frameworks, guidelines, and procedures
 </li>
 <li>
 Excellent communication skills, both written and verbal, in English; proficiency in additional European languages is a plus
 </li>
 <li>
 Highly organized with the ability to manage multiple projects and deadlines effectively
 </li>
 </ul>
</div>

Regulatory Affairs Specialist - Europe Cluster

Air Products

<div>
 At Air Products, our purpose is to bring people together to reimagine what&rsquo;s possible, collaborate and innovate solutions to the world&rsquo;s most significant energy and environmental sustainability challenges. Grow with us as we embark on building tomorrow together by being the safest, most diverse and most profitable industrial gas company in the world.
 
 
 
 Reimagine What&rsquo;s Possible
 
 
 
 <ul>
 <li>
 Liaise with government entities (GAFI, SCzone, Customs and IDA etc..) and service providers, to make sure that we are compliant with local requirements.
 </li>
 <li>
 Manage all licensing process requirements, environmental, operating, etc, and maintaining updates for the same.
 </li>
 <li>
 Liaise with functional departments to ensure that all legal documents, CR, tax card, etc, records are issued on time, and keep track of renewal dates, including proper filing and archiving.
 </li>
 <li>
 Maintain and organize company records, including files, databases, and correspondence, ensuring confidentiality and security.
 </li>
 <li>
 Support projects team in local admin requirements from initiation to completion.
 </li>
 <li>
 Coordinate with carrier and forwarders to ensure flawless shipping of equipment, and manages the Customs portal, while maintaining effective communication with project and business team&rsquo;s, to update them on shipment statuses..
 </li>
 <li>
 Prepare shipping documentation, shipment invoices, and customs forms as required.
 </li>
 <li>
 Track and resolve shipping-related issues, including delays and damages in coordination with the business teams.
 </li>
 <li>
 Build and maintain relationships with vendors, suppliers, and logistics partners.
 </li>
 <li>
 Utilize shipping software/ portal to track shipments efficiently.
 </li>
 <li>
 Managing local purchasing requests &amp; supplies, stationery and equipment, furniture, etc. for the entire staff in accordance with company purchasing policies and budgetary restrictions.
 </li>
 <li>
 Manage overall company transportation services for staff &amp; visitors when needed to ensure smooth workflow and quality service level.
 </li>
 <li>
 Support accounting teams in monthly closing by ensuring that all the transactions are properly posted on time in company ERP.
 </li>
 <li>
 Laise with functional departments to ensure that all the vendors invoices are paid on time.
 </li>
 <li>
 Coordinate with tax consultant for Filing the taxation.
 </li>
 <li>
 Responsible to receive and submit all the banking documents on behalf of the company.
 </li>
 <li>
 Assist with budgeting and expense tracking for projects and shipping activities.
 </li>
 <li>
 Maintain effective communication with business team&rsquo;s, to update them on shipment statuses.
 </li>
 <li>
 Build and maintain relationships with vendors, suppliers, and logistics partners.
 </li>
 <li>
 Responsible for the forecasting and budgeting process for all Admin related items.
 
 
 </li>
 </ul>
 We are the world&rsquo;s largest hydrogen producer with over 80 years of industrial gas experience. We are hydrogen and industrial gas experts delivering safe, end-to-end solutions, investing in real, clean energy projects at scale, and driving the industry forward to generate a cleaner future.
 
 
 At Air Products, we work in an environment where we put safety first, diversity is essential, inclusion is our culture, and each person knows they belong and matter. To learn more, visit About Air Products.
 
 
</div>

IQVIA

New Cairo, Egypt | Full time | Hybrid | R1527954
 <div>Job Overview 
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.<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>
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
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>

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