24 Regulatory Affairs Specialist jobs in the United Arab Emirates
Regulatory Affairs Specialist
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Company Description
Arthrex is a global medical device company known for new product development and medical education in orthopedics. With a mission to help surgeons treat their patients better, Arthrex has created over 12,000 innovative products and surgical procedures to advance minimally invasive orthopedics globally. The Arthrex Middle East Marketing Office, located in Dubai's Science Park, supports the educational needs of surgeons and distributors across the region. Composed of experienced healthcare professionals, the Dubai office serves as a hub for innovative ideas and expertise in the EMEA region. Arthrex maintains its family business culture despite global growth, committed to quality and positive contributions to medicine and communities worldwide.
Role Description
This is a full-time on-site role in Dubai for 6 months (renewable), for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. This role involves staying updated on regulatory affairs and collaborating with cross-functional teams to ensure adherence to regulatory standards.
Qualifications
- Experience in Regulatory Documentation and Regulatory Submissions
- Knowledge of Regulations and Market Access Requirements in MEA
- Knowledge of Regulatory Documents
- Strong attention to detail and organizational skills
- Excellent written and verbal communication skills in english
- Ability to work collaboratively in a team environment
- Bachelor's degree in a relevant field is preferred such as Pharmacy, Bio-Chemistry, Sciences or Regulatory Affairs
- First Experience in Medical Device industry is a plus
Regulatory Affairs Specialist
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About the job
About Kubbar International
Kubbar International is a leading international trading company specializing in veterinary products with operations across Egypt, KSA, UAE, Oman, and Kuwait. We are seeking a skilled and detail-oriented Regulatory Affairs Associate to join our Regulatory team in Dubai.
Job Overview
This position is to ensure that the company's products comply with local and international regulatory requirements. This involves developing and executing regulatory strategies, managing product registration processes, ensuring adherence to all applicable laws and regulations, and maintaining ongoing compliance throughout the product lifecycle. The specialist serves as a key liaison between the company and regulatory authorities, facilitating approvals and ensuring that all products meet the legal standards required for market entry.
Key Responsibilities
- Implement regulatory strategies to ensure that Kubbar International's products comply with local regulations.
- Ensure timely registration of new products and renewals of existing products.
- Maintain up-to-date knowledge of regulatory requirements and industry standards, ensuring company compliance at all times.
- Prepare, review, and submit high-quality regulatory submissions, including files, variation applications, and labeling updates.
- Ensure all technical documents are accurate, comprehensive, and comply with regulatory standards.
- Coordinate with cross-functional teams to compile required documents and data.
- Finalize the shipment documents and approvals in the ideal time plans.
- Ensure that product packaging, labeling, and promotional materials comply with regulatory standards.
- Ensure readiness for audits and inspections by regulatory authorities and respond promptly to any observations or non-compliances.
Qualifications and Requirements
- Bachelor's degree in Veterinary Science.
- Minimum of 1 year of experience in the vet products regulations.
- Experience in dealing with governmental entities.
- V.good English communication
- Strong attention to detail
- Ability to work in a multicultural environment
- Excellent interpersonal and communication skills
What We Offer
- Competitive salary package
- Comprehensive medical insurance
- Professional development opportunities
- Dynamic international work environment
- Career growth potential
How to Apply
Send applications to:
With the subject line "Regulatory Affairs Associate"
Kubbar International is an equal-opportunity employer committed to diversity and inclusion.
Regulatory Affairs Specialist
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The Compliance Officer is a key member of the MEA Legal and Compliance team, responsible for ensuring that Cigna's business in the UAE operates in compliance with all relevant laws and regulations.
As a senior compliance expert, you will work closely with colleagues in Legal and Compliance to provide accurate, proportionate, and timely compliance and regulatory advice to support Cigna's operational, strategic, and financial goals. You will maintain and enhance Cigna's compliance framework and program in the UAE, manage a team of direct reports to oversee compliance in the UAE, and influence and collaborate with business leaders, legal, audit, information protection, privacy, and compliance leadership to define, develop, and implement business unit compliance, privacy, and ethics programs.
Key Responsibilities:
- Maintain and enhance Cigna's compliance framework and program in the UAE.
- Manage a team of direct reports to oversee compliance in the UAE.
- Influence and collaborate with business leaders, legal, audit, information protection, privacy, and compliance leadership to define, develop, and implement business unit compliance, privacy, and ethics programs.
- Create an annual compliance plan for the UAE and the wider MEA region based on risk assessment.
- Establish and execute testing and monitoring plans against key compliance risks.
- Provide draft and final reports regarding testing and monitoring to legal and compliance leadership.
- Provide quarterly updates of progress against the compliance plan to legal and compliance leadership.
- Deliver compliance (regulatory and ethics) training to the business unit.
- Facilitate implementation of new compliance requirements by the first line of defense.
- Draft new compliance policies as needed.
- Provide guidance and support to the business unit in managing data and privacy issues, including breach management remediation plans, data subject access requests, and data privacy impact assessments.
- Assist the Legal team in identifying and interpreting new laws, regulations, and market practices.
- Be a champion for the Cigna Ethics program.
- Partner with the international privacy team to drive privacy compliance in the UAE.
- Lead and/or support compliance projects in the UAE or wider ME region.
Required Skills and Qualifications
The successful candidate will have at least 8 years of experience in the compliance field within Healthcare Insurance/Insurance in the United Arab Emirates. A strong understanding of insurance-related and data protection laws in the UAE is essential. The ideal candidate will be able to work independently, multitask, and prioritize effectively in a high-paced environment. Previous experience in leading teams or high-value strategic projects is necessary.
The successful candidate must have strong analytical, planning, and problem-solving skills. Excellent written and oral communication skills are required, along with the ability to provide guidance on complex matters in a clear and concise manner. Ability to present sound, persuasive rationale for ideas or opinions is also essential.
Benefits
This role is based in Dubai, UAE, and candidates preferably will have regional experience. Qualified applicants will be considered without regard to race, color, age, disability, sex, childbirth (including pregnancy), related medical conditions, sexual orientation, gender identity, expression, veteran or military status, religion, national origin, ancestry, marital or familial status, genetic information, or any other characteristic protected by applicable equal employment opportunity laws.
Regulatory Affairs Specialist
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We are currently seeking a detail-oriented Regulatory Affairs Specialist to support regulatory operations at our UAE-based manufacturing facility.
This role involves compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including GMP audits.
- Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.
- Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.
- Review and verify the correctness and regulatory alignment of Artwork AW prior to submission.
- Act as a key liaison between regional regulatory teams and site-based technical functions QA QC Production Engineering.
- Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.
- Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
- Implement proper version control, submission tracking, and document retrieval protocols.
- Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
- Ensure alignment with both international regulatory expectations and local UAE GCC requirements.
- Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
A Bachelor's or Master's degree in pharmacy is preferred. 2-5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry, is highly desired.
This role requires strong communication, collaboration, and coordination skills across technical and regulatory functions, as well as a high level of accuracy, attention to detail, and document management capabilities. The ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements is essential.
Senior Regulatory Affairs Specialist
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We are hiring a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers the GCC.
This role reports to the Director of Regulatory Affairs Business Development and is based in Egypt or the UAE.
Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities in the GCC.
Qualifications
At least 2-3 years of experience within the GCC, registering Pharmaceutical, GSL, and OTC products.
Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.
High proficiency in English and Arabic is essential.
Good understanding of regulations and related guidelines in the GCC.
Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.
Familiarity with eCTD regulatory dossiers is a must.
Pharmaceutical Regulatory Affairs Specialist
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Job Title: Senior Regulatory Affairs Professional
Job Description:The successful candidate will play a pivotal role in shaping the company's relationship with key government bodies, regulatory authorities, and public health institutions.
This senior leadership position requires a dynamic professional with a proven track record of navigating complex regulatory environments and driving strategic policy initiatives within the pharmaceutical sector.
The successful candidate will be responsible for advocating for favorable healthcare policies, ensuring compliance with regulatory frameworks, and building strong relationships with government stakeholders, all while aligning these efforts with the company's overall business objectives and growth strategy in the region.
Key Responsibilities:
Senior Regulatory Affairs Specialist
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We connect clients to markets and talent to opportunity. Our organization has a global presence with 4,500+ employees across six continents, serving over 300,000 commercial, institutional, payments, and retail clients.
We operate from more than 70 offices worldwide as a leading provider of innovative products and services for investors.
You can pursue a career in corporate, institutional investing, or retail client-facing roles within our organization's four business segments, offering endless potential for growth and progression.
Business Segment Overview:
Career Opportunities:
The Compliance Analyst supports the compliance team in ensuring regulatory adherence and internal policy implementation under the Associate Director of Compliance.
The role is diverse, including monthly and quarterly compliance monitoring tasks, responding to client requests, maintaining registers and records, issuing training courses, and supporting other compliance-related duties.
This position is ideal for an individual with experience in compliance or audit roles. They must possess exceptional organizational skills, be proactive, attentive, and able to switch between tasks effectively.
Key ResponsibilitiesDuties include but are not limited to:
- Conducting testing to ensure compliance with legislation, documenting outcomes, and saving evidence.
- Maintaining registers and trackers, participating in weekly meetings, and taking minutes.
- Logging and tracking compliance tasks and remedial actions.
- Assisting with Management Information, composing reports, and PowerPoint slides.
- Assisting with client KYC requests by gathering information and liaising with the client.
- Monitoring the compliance inbox to ensure timely matters.
- Supporting the team with day-to-day tasks, ad-hoc projects, and other duties as required.
Experience & Skills Required:
- Minimum 3 years' experience in a similar role.
- Strong attention to detail and organizational skills.
- Good knowledge of Microsoft Office, particularly Excel.
- Ethical understanding of compliance rules.
- Ability to develop relationships internally and with clients.
- Proactive, able to multitask effectively.
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Specialist - Regulatory Affairs
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At Julphar, we are on a journey of culture transformation and our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, Innovation, Integrity and Compassion — Combined with a focus on diversity, inclusion, and equal opportunities — are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents, create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Responsibilities- Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities.
- Prepare and submit the Registration dossiers for the health authorities in different countries as per their current guidelines.
- Respond to the queries received from the health authorities. 4. Review of outsourced registration dossier
- Review of open part API drug master file (APIDMF)
- Coordinate with the regulatory agents in countries, distributors, and other departments concerned with fulfilling the registration requirements.
- Update the product-specific APQR sheet, which comprises complete approved information related to the product at the time of approval in the related market.
- Ensure that all state and International regulatory requirements are addressed for the marketed products and New Product submission.
- Monitor proactively relevant governmental bodies to identify changes in legislation/regulations.
- Maintains knowledge of the current regulatory guidelines environment by reviewing and communicating current decrees policies/practices issued by Health Ministry.
- Maintain up-to-date documentation within the regulatory database
We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and the journey of Julphar
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Regulatory Affairs and Quality Specialist 524731
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Role MissionAs a Regulatory Affairs and Quality Specialist , you will act as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with applicable regulations and planned timelines.
What your responsibilities will be- You will support the Scientific Office Manager (SOM) in obtaining timely approvals for product registration, reregistration, and variations with the Saudi FDA.
- You will actively follow up on submissions to resolve any regulatory issues efficiently.
- You will anticipate and respond to regulatory and technical queries from competent authorities.
- You will assist in closing deficiencies or observations raised by regulatory bodies.
- You will monitor regulatory updates and ensure compliance with new legislation to develop effective regulatory strategies.
- You will manage regulatory correspondence between the company and competent authorities.
- You will review product artwork and promotional materials to ensure compliance with regulations.
- You will liaise with the local Qualified Person for Pharmacovigilance , supporting safety reporting compliance with local legislation, audits, and inspections.
- You will support the renewal of office licenses and ensure compliance with scientific office requirements.
To perform this job successfully, you must meet the following requirements:
- Education : Bachelor's degree in Pharmaceutical Sciences.
- Experience : 2-4 years in Regulatory Affairs or a related field.
- Skills :
- Strong knowledge of regulatory requirements and compliance.
- Excellent communication and stakeholder management skills.
- Ability to work in a fast-paced international environment.
- Detail-oriented with strong problem-solving abilities.
This is a great opportunity for someone with the right skills and mindset. You will be part of an international environment with opportunities to grow professionally in a critical function.
Information about Grifols is available at If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Location: Riyadh, KSA
For regulatory reasons, you must strictly be a Saudi national.
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Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law. We will consider for employment all qualified applicants in a manner consistent with the requirements of applicable state and local laws.
Location: EMEA: United Arab Emirates: Dubai: Dubai
Learn more about Grifols.
#J-18808-LjbffrRegulatory Affairs Manager
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Role: Regulatory Affairs Manager
Location: Abu Dhabi Role Purpose:
The Regulatory Affairs & FATCA/CRS Manager is the primary Point of Contact (PoC) / Designated FATCA CRS Officer for ADIB Group, who will maintain ADIB’s regulatory relationships with competent regulators including Central Bank of UAE (CBUAE) and Securities and Commodities Authority (SCA) and UAE Ministry of Finance and ensure that ADIB has in place a robust framework to meet its regulatory commitments in line with global standards for the automatic exchange of financial account information. Key accountabilities of the role include:
- Develop and maintain internal procedures, standards, self-certification processes and guidance checklists to Businesses and Group Entities in line with UAE Ministry of Finance, Central Bank of UAE and Competent Tax Authorities for compliance with FATCA & CRS policies and governance documents.
- Act as the subject matter expert (SME) in respect of FATCA & CRS for the function, businesses and support functions.
- Submit accurate and timely reporting to the various Competent Tax Authorities.
- Develop Data Validation processes to ensure completeness and accuracy of information received.
- Provide inputs to bank’s data governance framework to prescribe all required data to be captured and maintained within core banking systems from onboarding channels.
- Assess and propose enhancements and implement changes to procedures and internal systems for improved automation and end-to-end workflow and controls.
- Maintain relationships with Data Governance, Technology and Client On-boarding teams as required, for effective troubleshooting and successful end-to-end workflows.
- Provide support with Group Internal Audit requests, ensuring accurate information is provided in a timely manner.
- Provide Training guidance and advice on entity classifications and reportable information each financial year.
- Support the implementation and configuration of Reporting Tools and leveraging of AI.
Key Accountabilities of the role:
Policies and Procedures:
- Support in maintenance and update of Regulatory Affairs and Ethical Conduct related policies, procedures, and processes.
- Ensure the continuous monitoring and update of Regulatory Affairs Related policies by addressing regular updates to Head of Regulatory Affairs on their renewal status and market/regulatory evolution.
FATCA and CRS:
- Ensure the continuous review, enhancement and oversight of FATCA and CRS regulations, policies and procedures.
- Investigate, advise and challenge the onboarding documentation process and assessment of FATCA/CRS compliance risks associated to ADIB.
- Coordinate and finalize any ad-hoc gap assessment of the FATCA and CRS policies and procedures against updated regulatory requirements and ensure oversight or implementation throughout ADIB.
- Ensure continuous maintenance of training material (including role-based training) and upskilling on FATCA and CRS requirements and obligations to relevant staff across ADIB.
- Continuously support the review of Business Units systems to ensure the sound capture of FATCA/CRS indicia.
- Ensure the data accuracy and timely submission of the FATCA and CRS reporting expected by CBUAE and SCA on a yearly basis through their respective portal.
- Provide complete, accurate, practical and timely advice, opinion or documentation for regulatory ad-hoc enquiries raised by the regulatory authorities.
- Provide regulatory advisory on FATCA and CRS inquiries raised by Business Units/Branches system requirements and FATCA/CRS reporting.
- Ensure continuous update of FATCA and CRS mandate to all units of business (Retail Individual, Business banking, WBG, Financial institutions) in line with the applicable regulation.
- Participate in system enhancements regarding any regulatory update pertaining to implementation of FATCA and CRS.
Data Validation and Reporting:
- Support in the preparation of MIS reports for internal regulatory affairs reporting, including Management Committees.
- Support the preparation and maintenance of ADIB regulatory returns/reporting register and monitor adherence to defined due dates.
- Ensure the continuous validation of the Regulatory Reporting suite applicable to Regulatory Affairs and support their template design if not provided by regulatory authorities.
- Ensure reporting of material non-compliances/breaches in line with the prevailing policies in a timely manner.
Staff Ethical Behavior:
- Demonstrate strong adherence to ADIB Conduct Risk Pillars and Code of Ethics in terms of transparency, integrity, confidentiality, respect and collaborative workplace.
- Demonstrate strong adherence to ADIB ethical conduct framework in reporting any conflict of interest event or any witnessed behavior which breaches code of ethics to Human Resources.
- Ensure to participate in the transparency and trust culture within the bank by reporting in good faith any concerns, misconduct or malpractice through the Whistleblowing framework.
Specialist Skills / Technical Knowledge Required for this role:
- Advanced Degree in Finance, Business, or any related subject.
- 5+ years of experience with International Reporting, including Taxation and specialist knowledge of FATCA/CRS regulations reporting and operationalization.
- Ability to be independent and perform innovative thinking to solve complex problems with no established precedence while balancing risk, speed, and accuracy.
- Exemplary knowledge of the UAE regulatory environment, regulatory structures, market practice and industry groups.
- Good communication skills and ability to interact with various stakeholders throughout the bank. Ability to quickly acquire knowledge of new regulations, rules and their impact on business. Ability to adopt a problem-solving approach and autonomous work on dedicated tasks.
- Strong interpersonal skills with the ability to communicate with impact, build healthy professional connections, influence outcomes, and simplify complex topics into actionable recommendations for decision-making.
- Job Identification: 2478
- Posting Date: 11/12/2024, 06:37 AM
- Apply Before: 12/12/2024, 06:36 AM
- Locations: Abu Dhabi, Al Rowdah, Shk Rashid Bin Saeed St. 313 ADIB New Headquarters Branch, Sh. Zayed Main Branch Abu Dhabi United Arab Emirates, Abu Dhabi, AE