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manager of regulatory affairs

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

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

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)

Emirates

<div>
 
 Job Purpose
 
 
 
 Our Group Security team is a multi-faceted area of our organisation that develops and implements best-in-class security strategies across the Emirates network. We have set the benchmark in aviation security and are committed to providing an internationally recognised standard of service. At Emirates, our award winning security group provides a wide array of services, learning and development and an opportunity to work with leaders from around the World!
 
 
 As a Security Officer with the Regulatory Affairs unit, your role will be to work independently to ensure the coordination of all security actions pertaining to the requirements, processes, and procedures of Group Security policy are carried out appropriately. Investigate and analyse cases of non-conformity and come up with appropriate recommendations of counter measures and corrective actions. Contribute to the development of appropriate training and education materials and to put up appropriate recommendations to relevant stakeholders to enhance security procedures, process, and awareness in the pursuit of heightening the level of security barriers against acts of unlawful interference, misconduct and undesirable activity.
 
 
 
 In This Role, You Will
 
 
 
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 Monitor and control the daily discrepancy logs, conduct or direct investigation to establish the facts and present a well-considered recommendation to the line.
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 Review relevant areas of operation and examine personnel and case records to ensure that personnel conform to prescribed standards of appearance, conduct, and efficiency. Inspect the operations and observe activities in assigned area for evidence of inefficiency and misconduct.
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 Prepare reports in relation to the productivity and performance of staff as well as the operational readiness of the unit. Submit reports to the line and recommend action to be taken or changes in rules in accordance to the Group's policies and the standards outlined by Emirates Group Security Policy. Collate statistics, facts and other relevant evidence and present a comprehensive finding or conclusion to be considered by the next level of authority.
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 Cascade directions from senior management to ensure that these are carried out accordingly. May be required to contribute in the formulation of procedures, quality drive and human resource requirements.
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 In emergency cases, re-distribute members of security personnel where required e.g. in case of fire, ISU (Incident Support Unit) activation etc. to ensure that all operations in other areas are running smoothly and all security requirements are met.
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 Act as security liaison with the authorities e.g. the police, immigration, the prosecution branch, DAC (Dubai Airports Company) etc. in the day to day operation, investigation, planning, quality drive and the development of security programs.
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 Prepare procedures to identify security functions and measures which could assist in the overall prevention of acts of unlawful interference and misconduct. Support in maintaining the related manuals to ensure currency and take lead in the organisation's drive towards continuous improvement.
 
 
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 </ul>
 Qualification
 
 
 
 To be considered for this role, you must meet the below requirements:
 
 
 
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 Experience in aviation security in a supervisory position of an airline, ground handling company, aviation services business or other large services sector organization, ideally in a law enforcement environment.
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 Industry related certification i.e. aviation security from IATA, ICAO and other relevant recognised organisations.
 
 
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 </ul>
 
 You Will Have An Edge If You Have
 
 
 
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 Extensive legal knowledge and a good understanding of laws. As surveillance work is part of the job, investigators must also be aware of the legal limits of private investigation.
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 Experience of investigation and investigative techniques to solve problems or resolve disputes.
 
 
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 </ul>
 At Emirates Group, we&rsquo;re committed to providing our employees with opportunities to grow and develop their careers. If you&rsquo;re looking for a challenging and rewarding opportunity, apply today and join our team!
 
 
 Salary &amp; benefits
 
 
 Join us in Dubai and enjoy an attractive tax-free salary and travel benefits that are exclusive to our industry, including discounts on flights and hotel stays worldwide.
 
 
 Discover what it&rsquo;s like to live and work in our fast-paced, cosmopolitan home city by visiting the Dubai Lifestyle section on our career&rsquo;s website: www.emirates.com/careers.
</div>

Security Officer - Regulatory Affairs

Client of Tandem Search

Key Result Areas
<ul>
 <li>Prepare and submit accurate regulatory reports for the bank's subsidiaries and UAE operations in compliance with Central Bank guidelines and timelines.</li>
 <li>Prepare GDL and Cash Reserve returns and advise for entries for the UAE.</li>
 <li>Collaborate with cross-functional teams to gather, validate, and reconcile data for reporting.</li>
 <li>Address data issues with relevant departments to ensure reporting accuracy.</li>
 <li>Monitor regulatory changes and update reporting processes accordingly.</li>
 <li>Drive automation and process improvements in regulatory reporting in partnership with Technology.</li>
 <li>Conduct compliance assessments and support audits through proper documentation and timely responses.</li>
</ul>
Knowledge, Skills, and Experience
<ul>
 <li>Accounting or Finance graduate with 3 to 5 years experience in the accounting or finance function of a banking or non-banking financial institution.</li>
 <li>Strong analytical mindset and attention to detail.</li>
 <li>Clear and effective communication of complex regulatory concepts.</li>
 <li>Strong collaboration skills with the ability to lead cross-functional initiatives.</li>
 <li>Proficient in data validation, reconciliation, and analysis.</li>
 <li>Advanced skills in Microsoft Excel.</li>
</ul>

Assistant Manager Regulatory Reporting

Commercial Bank of Dubai

To manage teams and undertake audit work (as necessary) to support the delivery of the audit plan in accordance with audit methodology, to ensure risks are effectively managed in accordance with all relevant regulations. Principal Accountabilities: Work Management Manage and undertake reviews, as directed, in order to assess the adequacy and effectiveness of controls, systems, processes and procedures, highlighting areas of concern. Agree terms of reference with management and keep them informed of the assignment s progress and findings. Produce draft audit reports for HoA or CIAO review and provide to business management detailing the findings of reviews in order to make recommendations for improvements to the management and control of risk. Confirm that outstanding issues identified during reviews are followed up and resolved to ensure that risks are effectively managed in accordance with all relevant policies and regulations. Develop and manage relationships with senior management, colleagues and relevant external parties to discuss current and future issues and ensure their requirements and concerns are addressed. Advise and support management at all levels in understanding and accepting where corrective action needs to be taken in order to protect the Bank. As appropriate, pro-actively liaise with internal stakeholders and team members in order to discuss current and future issues; feed risks identified into the planning process. Ensure compliance with the Bank s policies, procedures and guidelines together with all relevant regulatory and statutory requirements where appropriate implementing actions to protect the Bank s business at all times. Recommend changes to policies, systems, processes and working practices in order to achieve operational improvement. Manage, motivate and develop team members as required, so that their individual and collective performance is of the required standard and meets the current and future needs of the business. Update Audit Universe as and when required.

Senior Audit Manager, FCC and Regulatory Compliance

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