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regulatory affairs specialist

Amgen

Associate Regulatory Affairs - based in Dubai Join to apply for the Associate Regulatory Affairs - based in Dubai role at Amgen.You'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-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What You Will Do Let's do this. Let'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's corporate and local regulatory requirements</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 (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications. Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>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.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> 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' 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 at 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.

Associate Regulatory Affairs - based in Dubai

Peergrowth Consultancy Co.

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.KEY RESPONSIBILITIES<ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul>CANDIDATE EXPERIENCE<ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul>Key Skills and Competencies<ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul>Coordinator • Dubai, United Arab Emirates

Regulatory Affairs Coordinator

VALTRANS TRANSPORTATION SYSTEMS & SERVICES

We are seeking a proactive and detail-oriented Regulatory Liaison Officer to join our dynamic parking management team in the UAE. In this role, you will serve as the vital link between our organization and regulatory authorities, ensuring full compliance with local laws and regulations while facilitating smooth communication and efficient approvals.Responsibilities:- Liaise with government bodies and regulatory agencies to ensure compliance with parking management laws and standards.- Monitor and interpret changes in regulations affecting the parking industry and advise internal teams accordingly.- Prepare, submit, and follow up on all necessary documentation and permits required for operations.- Coordinate with legal and compliance departments to manage audits and inspections.- Develop and maintain strong relationships with regulatory authorities to facilitate prompt resolution of issues.- Conduct internal compliance training sessions and workshops for staff.- Assist in developing company policies to align with regulatory requirements.- Report regularly on regulatory updates and compliance status to management.Skills and Qualifications:- Bachelor&rsquo;s degree in Law, Public Administration, Business, or a related field.- Minimum of 3 years of experience in regulatory affairs, preferably within parking management or related industries.- Strong understanding of UAE regulatory frameworks and government operations.- Excellent communication and interpersonal skills, with the ability to build effective relationships with authorities and stakeholders.- Detail-oriented with strong organizational and documentation skills.- Ability to work independently and manage multiple tasks in a fast-paced environment.- Proficiency in English; knowledge of Arabic is an advantage.- Problem-solving mindset and a proactive approach to compliance challenges.Job Type: Full-timePay: AED7,000.00 - AED15,000.00 per monthExperience:<ul><li>Regulatory Liaison Officer: 3 years (Required)</li><li>RTA / Municipality: 3 years (Required)</li></ul>License/Certification:<ul><li>UAE Driving License (Required)</li></ul>Work Location: In person

Regulatory Liaison Officer

IQVIA

No visa or accommodation sponsorshipYou will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.JOB OVERVIEWEssential Functions<ol><li>Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.</li><li>Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.</li><li>Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.</li><li>Artwork review and approval in client systems.</li><li>Manage multiple pharmaceutical products.</li><li>Act as subject matter expert in regulatory processes.</li><li>Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.</li><li>Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.</li><li>Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.</li><li>Project budget management.</li><li>Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.</li><li>Possible exposure to present to clients on complex regulatory processes and bid defense meetings.</li><li>Act as reviewer for regulatory standard operating procedures.</li><li>Prepare and deliver internal regulatory training if required.</li></ol>MINIMUM REQUIRED EDUCATION AND EXPERIENCEExperience: Typically requires 8-10 years of prior relevant experience.Education: Masters Degree in Life Sciences or related discipline.Skills and Abilities:<ul><li>Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.</li><li>Possesses specific regulatory or technical expertise.</li><li>Interpersonal communication (oral and written) and organization skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li><li>Demonstrates self-motivation and enthusiasm.</li><li>Ability to adapt quickly to a rapidly changing environment.</li><li>Knowledge of Maintenance of Marketing Authorization.</li><li>Experience of preparing variation renewal packages and artwork approvals.</li><li>Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.</li><li>Must be fluent in Arabic.</li></ul>IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at

Global Regulatory Affairs Manager (homebased)

AL ALI TECH LLC

Government Liaison<ul><li>Act as the official point of contact between the company and various UAE government departments (e.g., Ministry of Labour, Immigration, DED, Municipality, Free Zone Authorities).</li><li>Facilitate communication and documentation submission to authorities.</li></ul>Visa &amp; Immigration Services<ul><li>Handle all visa processes for employees and their families (employment, residence, dependent visas).</li><li>Coordinate with immigration offices for entry permits, visa stamping, cancellations, and renewals.</li></ul>Labour &amp; Employment Formalities<ul><li>Process work permits and labour cards for new hires.</li><li>Renew and cancel labour cards as required.</li><li>Handle employment contract submissions and amendments</li><li>Assist in setting up new businesses: trade name reservation, initial approvals, trade license issuance.</li><li>Renew and amend existing trade licenses.</li><li>Coordinate legal translations, notarizations, and attestation of documents.</li></ul>Regulatory Compliance<ul><li>Ensure the company remains compliant with UAE regulations (e.g., ESR, VAT registration, UBO, AML compliance where applicable).</li><li>Maintain company records in line with government requirements.</li></ul>Document Clearance<ul><li>Submit and collect documents from ministries, embassies, and other government bodies.</li><li>Arrange attestations from the Ministry of Foreign Affairs (MOFA), embassies, etc.</li></ul>Employee Onboarding &amp; Offboarding<ul><li>Guide new employees through visa medicals, Emirates ID applications, and orientation regarding UAE laws.</li><li>Handle final exit procedures and visa cancellations when employees leave.</li></ul>Renewals &amp; Updates<ul><li>Ensure timely renewal of:</li><li>Trade licenses</li><li>Emirates IDs</li><li>Visas</li><li>Health insurance</li><li>Tenancy contracts linked to company operations</li></ul>Job Types: Full-time, PermanentPay: AED3,500.00 - AED4,000.00 per monthApplication Question(s):<ul><li>Do you have UAE Driving license?</li></ul>Experience:<ul><li>PRO: 5 years (Required)</li></ul>

Public Relations Officer (PRO)

<div>
 
 
 KOA
 
 is looking for an experienced and dedicated
 
 Public Relations Officer (PRO)
 
 to join our team and manage all aspects of governmental and legal compliance for our operations. The ideal candidate will have strong experience in dealing with various authorities and will ensure that all licenses, permits, and documentation are up to date, complying with all local regulations within the real estate and construction industry.
 
 
 Key Responsibilities:
 
 <ul>
 <li>
 
 Permit &amp; Document Approval
 
 : Extensive knowledge and experience in navigating the permit and document approval processes with the Dubai Development Authority (DDA) and other relevant government agencies. This includes securing building permits, zoning approvals, construction-related licenses, and ensuring compliance with regulations from entities such as the Dubai Lands Department, Dubai Municipality, Civil Defense, and the RTA. The ideal candidate will have a strong understanding of the legal and procedural requirements specific to real estate development, construction projects, and related construction certifications.
 </li>
 <li>
 
 Licensing &amp; Renewals
 
 : Manage the establishment, renewal, replacement, and cancellation of business licenses in Dubai, particularly for real estate property development, construction, and related projects. This includes handling license cancellations, advertising requirements, and obtaining necessary NOCs from landlords, DEWA, and relevant authorities.
 </li>
 <li>
 
 NOCs &amp; Approvals
 
 : Obtain NOCs from immigration, labor, and other related departments, as well as necessary approvals from the Economic and/or Tourism Departments for events or advertisements in real estate and construction projects.
 </li>
 <li>
 
 Commercial Registrations &amp; Certificates
 
 : Issue commercial registrations, trade names, register trademarks, and facilitate obtaining membership certificates and/or Chamber of Commerce certificates for property development and construction businesses.
 </li>
 <li>
 
 Government Transactions
 
 : Facilitate and clear transactions with various government departments, including the Ministry of Economy, Trade and Industry, Dubai Lands Department, Dubai Development Authority, Tenancy, Civil D&eacute;fense, Municipality, Traffic Departments, MOHRE, Dubai Immigration &amp; ICA, RTA, DEWA, contract authentication and legal translation, as well as resolving labor issues with the Ministry of Labor and any other required government entities.
 </li>
 <li>
 
 Employee Permits, Residency &amp; Emirates ID
 
 : Issue, renew, and cancel residency permits for employees working in the real estate development and construction sectors.
 </li>
 <li>
 
 P.O. Box Renewal
 
 : Manage P.O. Box renewals in Dubai.
 </li>
 <li>
 
 Additional Support
 
 : Provide assistance and advice on property-related matters to ensure smooth company operations and compliance in the real estate development and construction industry.
 </li>
 </ul>
 
 
 Requirements:
 
 
 <ul>
 <li>
 Proven experience as a PRO in Dubai, with a deep understanding of local laws and regulations.
 </li>
 <li>
 Preference will be given to UAE Nationals.
 </li>
 <li>
 Strong communication skills and the ability to interact with government departments and authorities.
 </li>
 <li>
 Detail-oriented and organized with the ability to handle multiple tasks simultaneously.
 </li>
 <li>
 Knowledge of all necessary documentation and processes for government approvals, visa renewals, and business compliance in real estate, development projects.
 </li>
 <li>
 Familiarity with
 
 UAE labor laws
 
 , immigration procedures, tenancy requirements, and construction-related regulatory requirements.
 </li>
 <li>
 A valid UAE driving license and personal transportation is a plus.
 </li>
 </ul>
 
 
 
</div>

هيئة الطرق والمواصلات

<div>أخصائي رئيسي - أنشطة النقل التجارية - (25001670)<div>
الوصف الوظيفي<div></div> 
KEY RESULTS ACCOUNTABILITIES
# Contribute to the development, implementation, and updating of strategic plans and projects, and follow up on their implementation and updating to ensure their alignment with the RTA strategy and goal
# Develop and update policies and procedures manual in the administration and ensure their compatibility with the objectives of RTA
 # Develop department KPIs and ensure that individual KPIs are achieved to improve efficiency and effectiveness
# Follow-up to ensure the implementation of projects and initiatives in coordination with project managers according to approved plans # Proactively examine future trends in the commercial transport sector and make recommendations to support decision-making
# Ensure compliance with regulations and their governance for the issuance of business permits for commercial transport
# Conduct normative studies and comparisons in the field of legislation and policies for commercial transport and come up with recommendations that would develop the sector through development initiatives to support decision-making on commercial activities and future directions in accordance with global best practices
# Assess the regulatory and legal environment for logistical transport in the Principality and highlight policies and laws that can be improved to support development and growth in this sector
# Active participation in steering committees, subcommittees and various major project teams
 # Perform other functions and responsibilities associated with the job and as assigned to it - Strictly Adhere to RTA Information Security policies, procedures, and processes. -<div> 
</div></div><div>
المؤهلات و المهارات<div></div> 
Education
 # Bachelor's degree in Business Administration/Quality Management or equivalent from a recognized university. 11 years of working experience<div> 
</div></div><div>
فئة الوظيفة: الجودة و التميز</div><div>
جهة العمل: هيئة الطرق والمواصلات</div><div>
الإدارة: أنشطة النقل التجارية</div><div>
المستوى التعليمي: بكالوريوس</div><div>
الجنسية المطلوبة: جميع الجنسيات (الأولوية للمواطنين)</div><div>
الراتب الشهري: غير محدد</div><div>
طبيعة الدوام: دوام كامل</div><div>
تاريخ الإعلان: 22-12-2025</div><div>
تاريخ سحب الإعلان عن الوظيفة: 21-01-2026</div></div>

أخصائي رئيسي - أنشطة النقل التجارية

Explore 1102+ Regulatory affairs specialist in Dubai United Arab Emirates this January. Find roles across top companies and apply now to boost your career.

1102 regulatory affairs specialist jobs IN Dubai United Arab Emirates

Associate Regulatory Affairs - based in Dubai

Regulatory Affairs Coordinator

Regulatory Liaison Officer

Global Regulatory Affairs Manager (homebased)

Public Relations Officer (PRO)

Public Relations Officer (PRO)

أخصائي رئيسي - أنشطة النقل التجارية