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regulatory affairs manager

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)

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

Besins Healthcare

Key Responsibilities:<ul><li>Acts as responsible Regulatory Team member for assigned regulatory projects.</li><li>Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).</li><li>Prepares and/or reviews regulatory documentation for National applications in line with assigned timelines.</li><li>May support on some R&amp;D regulatory projects.</li><li>Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team</li><li>Understands the Scope of Work, timelines and deliverables for a given project.</li><li>Prepare status reports and metrics for assigned projects.</li><li>Perform assigned work according to current best good regulatory practice/guidelines in compliance with current legislation.</li><li>Any other duties as assigned by your manager.</li><li>Learn, develop, and train.</li></ul>_Technical Skills/ Experience_<ul><li>&gt;4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.</li><li>Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.</li><li>Experience of GCC markets/ICH guidelines/MHRA guidelines</li><li>Experience of emerging markets / international RoW markets and regulatory filings.</li><li>Quality control review of technical/ regulatory documents.</li><li>Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.</li><li>Publishing: eCTD and or NEES.</li><li>Pharmaceutical artwork review and sign-off.</li><li>Project management experience - an advantage.</li><li>Experience of Women s and/or Men s healthcare an advantage</li></ul>_Soft Skills_<ul><li>Ability to work to tight timelines and manage peaks in workload.</li><li>Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.</li><li>Positive can-do attitude in growing company with expanding range of therapeutic product range.</li><li>Good negotiating skills and the ability to identify and resolve issues with external stakeholders.</li><li>Excellent verbal and written communication skills.</li><li>Excellent computer skills e.g. Word, Excel, data and document management systems.</li><li>Cultural awareness for global ways of working.</li><li>Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.</li><li>Desire to grow regulatory operational and regulatory strategy experience.</li><li>Languages: Speaking &amp; Writing French is a Must- Fluent Arabic/English Required as well.</li></ul>_Minimum required education and experience_<ul><li>Degree in Pharmacy or life science-related degree plus at least 4-5 year s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia</li></ul>

Regulatory Affairs Officer

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

Live 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> Win 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 SOP s. </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> Thrive 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 for a career that defies imagination Objects in your future are closer than they appear. Join us.

Associate Regulatory Affairs

Amazon.com

<div><h2 class="jobSectionHeader">DESCRIPTION</h2><div>
Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. We are driven by the excitement of building technologies, inventing products, and providing services that transform lives. We embrace new ways of doing things, make decisions quickly, and are not afraid to fail. We have the scope and capabilities of a large company, and the spirit and heart of a small one. 
Role Overview 
We are seeking an experienced Senior Compliance Manager to lead our compliance program across UAE and support the AMET (Africa, Middle East, and Turkey) region when needed. In this role, you will develop and implement compliance strategies that protect Amazon's reputation, customers, and business operations while enabling continued growth in diverse regulatory environments. You will collaborate with senior leadership, and serve as the primary point of contact with regulatory authorities across the region. 
 
About the team 
We are a diverse, upbeat, creative and passionate, team. We are owners of our scope and results oriented. We are empowered to adapt our timeline to our personal needs if needed for a better work/life balance. 
GES Values: 
<ul><li>SAFETY FIRST. We continuously seek improvement and innovation in Safety, raising the bar above industry norms and setting a new global standard.</li><li>PEOPLE OBSESSION. We understand the value of listening, promote diversity, lead by example and work together to achieve more, while remembering to have fun.</li><li>CHALLENGE THE NORM. We challenge each other and the industry to try new methods of working, and make a SAFER and more SUSTAINABLE environment. We are human, and not afraid to learn from our mistakes, and keep going!</li><li>MAKE AN IMPACT. We leverage efficient time management to ensure capacity for HIGH QUALITY execution alongside INNOVATION and Thinking Big.</li><li>TRUST. We build trust with our Customer, making ambitious but realistic commitments.</li></ul></div><h2 class="jobSectionHeader">
BASIC QUALIFICATIONS</h2><ul><li>Bachelor's degree in Law, Business, Finance, or related field</li><li>8+ years of professional experience in compliance, regulatory affairs, or legal roles</li><li>Demonstrated experience developing and implementing compliance programs in the AMET region, with specific expertise in UAE regulatory frameworks</li><li>Experience engaging with regulatory authorities and managing regulatory relationships</li><li>Strong understanding of e-commerce, digital services, or retail compliance requirements &bull; Excellent written and verbal communication skills in English</li><li>Proven ability to influence without authority across multiple levels of an organization</li><li>Experience managing budgets and resources for compliance programs</li></ul><h2 class="jobSectionHeader">
PREFERRED QUALIFICATIONS</h2><ul><li>Speak, write and read fluently in either of these preferred languages: French, Polish, Arabic, Turkish, Afrikaans, Zulu and Portuguese.</li><li>Master's degree or professional qualification in Law, Compliance, or related field with 8+ years of experience in compliance roles with progressive responsibility</li><li>Experience with multiple regulatory frameworks across AMET countries</li><li>Experience in a multinational corporation with complex regulatory requirements</li><li>Professional certifications such as CCEP or equivalent</li></ul> 
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you&rsquo;re applying in isn&rsquo;t listed, please contact your Recruiting Partner.</div>

Regulatory/Compliance Manager

Confidential Company

An International pharmaceutical company based in HQ in Dubai is looking to appoint an officer in its regulatory affairs department. The candidate should be a Pharmacist preferably with postgraduate studies in any scientific field, fluent in English and has at 1-2 years’ experience in registration of medicines. MOH license is mandatory and knowledge in Pharmacovigilance would be a plus.

Pharma Regulatory Affairs Officer

Explore 4741+ Regulatory affairs manager in Dubai United Arab Emirates this November. Find roles across top companies and apply now to boost your career.