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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>

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

The UAE National Public Relations Officer (PRO) is responsible for ensuring that the company and its group comply with all government regulations and requirements. This role is pivotal in managing the company&#x27;s interaction with governmental and regulatory bodies. The PRO will handle various government-related tasks in a timely and efficient manner, ensuring smooth operations across departments.<ul><li>Manage and oversee all government-related processes, including visa applications, labor permits, and trade licenses, ensuring strict adherence to UAE regulations.</li><li>Serve as the primary liaison between the company and government entities, fostering strong relationships to facilitate smooth operations.</li><li>Prepare and submit all required documentation accurately and promptly, minimizing delays and ensuring compliance.</li><li>Monitor changes in UAE labor laws and regulations, proactively updating company policies and procedures.</li><li>Coordinate and manage employee onboarding and offboarding processes, ensuring all legal requirements are met.</li><li>Maintain and update employee records, ensuring confidentiality and compliance with data protection regulations.</li><li>Provide guidance and support to employees on PRO-related matters, addressing queries and resolving issues efficiently.</li><li>Oversee the renewal of company licenses and registrations, ensuring they remain current and valid.</li><li>Conduct regular audits of PRO-related documentation and processes to identify and mitigate risks.</li><li>Negotiate and liaise with government departments to resolve any issues or disputes related to PRO matters.</li></ul><ol type="1"><li> Government Liaison Services:</li></ol><ul><li>Provide prompt, efficient, and reliable services for all government-related tasks such as processing entry permits, visas, and medical examinations.</li><ul><li>Handle miscellaneous jobs related to immigration, the Ministry of Labour, and other government bodies, ensuring full compliance with all regulations.</li><li>Stay updated and implement changes in rules and regulations, adapting to amendments within short notice.</li></ul></ul> <ol type="1"><li>License and Permit Management:</li><ul><li>Oversee the renewal of company trade licenses and other required permits.</li><li>Ensure timely renewal of all relevant governmental documents to maintain the company&#x27;s legal standing.</li></ul></ol> <ol type="1"><li>Document Attestation:</li><ul><li>Handle the attestation of company and employee documents from embassies and relevant government departments.</li><li>Ensure all documents are properly processed and certified for legal and business purposes.</li><li>Prepare Arabic Letters </li></ul></ol> <ol type="1"><li>Coordination with Government Authorities:</li><ul><li>Act as the main point of contact between the company and government authorities, including immigration, labour departments, consulates, and other regulatory bodies.</li><li>Ensure the company interests are represented effectively and all dealings are conducted professionally.</li><li>Responsible for coordinating and liaising between the company and government organizations authorities. </li><li>Provide Quick, Efficient and reliable services for all Government related jobs such as Entry Permits, Entry Visas, Medical Examinations, Miscellaneous jobs related to Immigration, Ministry Labor, Consulates and Business Licenses to the company and its group, adhering to the regular amendments in rules and regulations within very short notices. </li></ul></ol> <ol type="1"><li>Administrative Duties:</li><ul><li>Perform general administrative and clerical duties as required, such as managing paperwork, filing documents, and maintaining an organized system of records.</li><li>Assist with various office operations and ensure compliance with governmental protocols</li><li>Responsible for maintaining accurate records for all public relations tasks. </li><li>Undertake general administrative and clerical duties as required. </li><li>Collaborate with internal teams to gather corret details and information as required. </li><li>Assist to prepare and organize the PRO Documents for daily works. </li><li>Keep calendars list for the PRO follow up daily works.</li></ol></ul>

UAE NATIONAL PRO COORDINATOR

ARMS Group

Job Purpose:To handle the registration and approval process of veterinary medicines and related products with MOCCAE and other relevant UAE authorities, ensuring compliance with all regulatory and legal requirements.Key Responsibilities:<ul><li>Prepare, compile, and submit registration dossiers for veterinary medicines to MOCCAE.</li><li>Ensure all product documentation (composition, labels, safety data sheets, GMP certificates, etc.) meets regulatory standards.</li><li>Liaise with MOCCAE officials and follow up on application progress, queries, and approvals.</li><li>Maintain up-to-date knowledge of UAE regulations and guidelines concerning veterinary pharmaceuticals and feed additives.</li><li>Coordinate with manufacturers and suppliers to obtain necessary documentation and certificates.</li><li>Ensure compliance with import, labeling, and storage requirements for veterinary products.</li><li>Maintain regulatory files and databases, ensuring timely renewal of product registrations.</li></ul>Bachelor&rsquo;s degree in Pharmacy, Animal Science, Biotechnology, or a related field.Job Type: Full-time

Registration Liaising coordinator

Trade Quo Global Ltd

The Compliance Officer ensures full adherence to Securities and Commodities Authority (SCA) regulations and serves as the company's Money Laundering Reporting Officer (MLRO) in the UAE. This role is critical under SCA licensing requirements. Additionally, the Compliance Officer will oversee and coordinate compliance practices across the broader global group, including Malaysia, Thailand, South Africa, Cyprus, and Colombia, ensuring consistent standards and adherence to local regulatory frameworks.Key Responsibilities:UAE / SCA Responsibilities <ul><li>Develop, implement, and maintain a comprehensive compliance framework aligned with SCA regulations.</li><li>Submit required SCA reports, including compliance statements, STRs (Suspicious Transaction Reports), and other regulatory filings.</li><li>Act as the main point of contact with the SCA and other UAE regulators.</li><li>Monitor marketing materials and client onboarding processes for regulatory compliance. Conduct internal compliance audits and risk assessments.</li><li>Maintain and enforce the company&rsquo;s AML/CTF policies; ensure risk-based client reviews and KYC procedures.</li><li>Train UAE staff on compliance, AML, and SCA rules.</li><li>Stay updated on regulatory changes and ensure policies are updated accordingly.</li></ul>Global Group Responsibilities <ul><li>Oversee compliance operations across the group (Malaysia, Thailand, South Africa, Cyprus, and Colombia), ensuring alignment with local regulatory requirements and international standards (FATF).</li><li>Provide guidance to local teams on developing policies, risk assessments, and AML/CTF procedures in line with each jurisdiction&rsquo;s legal requirements.</li><li>Review and approve local compliance reporting, including suspicious transaction reports, audits, and regulatory filings.</li><li>Coordinate training programs and compliance workshops for global teams.</li><li>Monitor emerging regulatory developments in all group jurisdictions and assess impact on policies and processes.</li><li>Support local teams in regulatory inspections or audits and act as a liaison with international regulators when necessary.</li><li>Ensure consistent risk-based client due diligence and KYC across all markets.</li><li>Promote a strong compliance culture across the group and advise management on compliance-related strategic decisions.</li></ul>Requirements:<ul><li>Bachelor&rsquo;s degree in Law, Finance, Business, or related discipline.</li><li>Must hold or be willing to obtain ACAMS, CISI / ICA certifications (as required by SCA).</li><li>3&ndash;5 years of experience in compliance, ideally within a regulated financial services firm. Deep understanding of SCA rules, UAE AML laws, and international standards (FATF). Knowledge of regulatory requirements in Malaysia, Thailand, South Africa, Cyprus, and Colombia is highly desirable.</li><li>Strong attention to detail, independence, and ethical judgment.</li><li>Excellent communication skills for cross-jurisdiction coordination.</li><li>Must be resident in the UAE and pass the SCA fit &amp; proper test.</li></ul>Job Type: Full-timePay: From AED25,000.00 per monthApplication Question(s):<ul><li>How many years of professional experience do you have in compliance, AML/CTF, or regulatory affairs within financial services or brokerage firms?</li><li>Do you currently reside in the UAE and hold valid work authorization?</li></ul>(This role requires an on-site presence as part of SCA licensing compliance.)<ul><li>What is your expected monthly salary in AED ?</li><li>What is your current notice period or earliest availability to start?</li><li>In one or two sentences, please describe how you would promote a strong compliance culture within a global organization.</li><li>Are you currently certified or in the process of obtaining any compliance or AML certifications (ACAMS, CISI, ICA)?</li></ul>(Please indicate which certifications you hold or plan to obtain.)<ul><li>Do you have experience managing or coordinating compliance operations across multiple jurisdictions (Malaysia, Thailand, Cyprus, South Africa, Colombia)?</li></ul>

Compliance Officer

Explore 1812+ Regulatory affairs officer in Dubai United Arab Emirates this November. Find roles across top companies and apply now to boost your career.