regulatory affairs officer

Amros Pharmaceuticals

Regulatory Affairs Officer.We seek a highly motivated individual with a Doctor of Pharmacy (PharmD) degree and 6 months to 1 year of experience in the pharmaceutical industry (Regulatory Affairs or a related function preferred).Key ResponsibilitiesAssist in compiling and submitting CTD/eCTD dossiers to health authorities.Support the coordination of responses to regulatory agency queries.Research and monitor global regulatory guidelines (ICH, FDA, EMA) for compliance.Maintain accurate regulatory documentation and archives.RequirementsPharmD degree.6-12 months of relevant pharma industry experience.Strong attention to detail and excellent communication skills.Job Type: Full-timeWork Location: In person

Regulatory Affairs Officer

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

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>

UTOPIA INDUSTRIES PVT LTD

Regulatory Compliance Officer/ Specialist &ndash; Dietary SupplementsEducation: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.Experience: Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.KeyResponsibilities:<ul><li>Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&amp;C Act and 21 CFR 111 (cGMP).</li><li>Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.</li><li>Ensure scientific substantiation of ingredient functions and claims.</li><li>Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).</li><li>Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.</li><li>Evaluate supplier test data for microbial, heavy metals, and purity compliance.</li><li>Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.</li><li>Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.</li><li>Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.</li><li>Support packaging and labeling approval cycles before production.</li></ul>Job Type: Full-timeWork Location: In person

Regulatory Affairs Specialist

Chimera steel contracting llc

Job Title: PRO / Government Relations Officer Location: Dubai, UAE Employment Type: Full-timeAbout the Company: We are a dynamic company operating in [Industry &ndash; e.g., Construction / Engineering / Consultancy] based in Dubai. We pride ourselves on managing large-scale projects and ensuring full regulatory compliance in the UAE.Key Responsibilities:<ul><li>Manage all visa applications, renewals, cancellations, and labour card processes with Ministry of Human Resources &amp; Emiratisation (MOHRE) and other agencies.</li><li>Handle Emirates ID registration/renewals, immigration formalities, and relevant government-portal submissions (e.g., Tasheel, Amer, General Directorate of Residency &amp; Foreigners Affairs &ndash; Dubai (GDRFA)). Dr Jobs UAE+2Dubai Job Center+2</li><li>Process trade-license renewals, amendments, external approvals and coordinate with authorities such as Dubai Department of Economic Development (DED) and Free-Zone authorities. Dubai Job Center+1</li><li>Serve as the company&rsquo;s liaison with government departments, maintain document logs, monitor expiry of licenses/visas, and ensure compliance with UAE labour &amp; immigration laws. Dr Jobs UAE</li><li>Provide support to Admin/HR functions in government-relations tasks, scheduling appointments, document collections/deliveries, and general administrative assistance.</li></ul>Requirements:<ul><li>Strong working knowledge of UAE labour &amp; immigration laws and procedures.</li><li>Proficiency in Arabic and English (reading, writing, verbal) is an advantage.</li><li>Valid UAE Driving Licence preferred.</li><li>Excellent organisational, multitasking, and communication skills. Attention to detail and a result-oriented mindset.</li><li>Ability to operate independently, follow up with authorities, and handle confidentiality with integrity.</li></ul>Job Type: PermanentPay: From AED3,000.00 per month

Public Relations Officer

Acino

<div>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
This position is based in Cairo, Egypt and will report directly to the Regulatory Affairs Manager, META. The role will be responsible to support on all the assigned Regulatory activities within the Non-Direct Markets (NDM) region (Sudan, Libya, Yemen, Morocco, Jordan and Lebanon). The role will also ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs. Manage Business Partners within the NDM region. 
Your Responsibilities will be: 
<ul>
<li>
Support the Regulatory Affairs Manager on all the assigned Regulatory activities within the NDM.</li>
<li>Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.</li>
<li>Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).</li>
<li>Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.</li>
<li>Responsible of ordering and legalization of local CPP and other module 1 documents for local products.</li>
<li>Perform regulatory due diligence on module 1 for all assigned products for NDM according to internal process/guidance according to EU/local Region regulatory requirements.</li>
<li>Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.</li>
<li>Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.</li>
<li>Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.</li>
<li>Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.</li>
<li>Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.</li>
<li>Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.</li>
<li>All trainings to be completed as per training plan.</li></ul> 


Your Profile: 
<ul>
<li>
Education in Pharmacy, natural Sciences or relevant discipline.</li>
<li>Minimum of 3 years&rsquo; experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.</li>
<li>Proven ability to effectively work collaboratively in cross functional teams.</li>
<li>Ability to work in a highly dynamic business environment.</li>
<li>Cross-cultural awareness and ability to work across geographical markets.</li>
<li>Multi-task ability and work well under pressure and tight deadlines.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Regulatory Affairs Specialist NDM

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

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Associate Regulatory Affairs - based in Dubai