24 Regulatory Affairs Managers jobs in the United Arab Emirates

• Manage registration and approvals through DM / Montaji for food and consumer products.
• Handle MOHAP registration for GSL (General Sale List) items, medical equipment, and conventional products.
• Coordinate with relevant authorities to ensure timely approvals and renewals.
• Prepare and submit technical dossiers as per regulatory requirements.
• Maintain up-to-date knowledge of regional regulatory guidelines.

• 1–2 years of experience in UAE regulatory affairs.
• Proven experience with DM / Montaji systems and MOH product registration.
• Strong organizational and documentation skills.
• Arabic speaking is an advantage.
• Bachelor's degree in pharmacy, life sciences, or a related field preferred

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

Key Accountabilities

• Support and manage interface with relevant stakeholders as appropriate to engage, track, obtain and streamline business input/ objectives in key operational areas with regulatory requirements under the telecoms regulatory framework and/or the Telecommunications Digital Government and Regulatory Authority (TDRA) as may be required (e.g. in relation to specific TDRA requests for information, broader regulatory obligations, special projects and/or any other matter falling within the scope of the above framework).
• Act as primary interface with the TDRA's Technical Affairs personnel and eitc's Technology and Commercial teams in relation to daily management of eitc's requirements for scarce resources and eitc's compliance to:
• Internet access policy
• Mobile number portability
• Fixed number portability
• Numbering management
• National crisis management projects
• Billing and CPR audits
• in addition to TDRA's requests for actions and & adhoc reports within TDRA's timelines.
• Manage monitoring of international regulatory developments and international best practice, including supporting submissions/ policy positions with benchmarked data and in relation to recurring team updates as appropriate.
• Assist in the development of comprehensive planning and processes to ensure that responses to regulatory technology obligations are met.
• Support development and implementation appropriate overall performance measures in respect of eitc's obligations in respect regulatory compliance.
• Liaise with Technology, Finance and Commercial and other divisions as required to fulfill the duties of the position;
• Prepare and support the preparation of submissions, correspondence and other documentation relevant to the policies associated with these matters, and the operation of the policies in the fulfillment of the duties of the position;
• Represent Regulatory Affairs in meetings with the TDRA, Etisalat and other licensed operators, and in appropriate Industry fora, with a view to influencing regulatory outcomes to the benefit of eitc.

Qualifications:

• Bachelor's degree

Experience:

• 7-12 years of relevant industry experience

Skills:

• Excellent spoken and written communication skills in English and Arabic.
• Understanding of telecommunications and technologies.
• Ability to work independently or as part of a team.
• Result and outcome-oriented with attention to detail and quality within required timelines.
• Flexibility and ability to travel at short notice to meetings, including in Dubai and Abu Dhabi.

We're Hiring: Regulatory Affairs Associate – Full-Time | On-Site | Dubai

Join our team in Dubai as a Regulatory Affairs Associate. You'll be responsible for preparing and submitting regulatory documentation, ensuring compliance with relevant laws, and collaborating with internal teams to support regulatory processes.

Key Responsibilities:

Prepare and manage regulatory submissions and documentation

Ensure compliance with local and international regulatory requirements

Coordinate with cross-functional teams to meet submission timelines

Requirements:

Experience in regulatory documentation & submissions

Solid knowledge of regulatory compliance and requirements

Strong communication skills (written & verbal)

Bachelor's degree in a relevant field

Ability to work independently and in a team

Experience in corporate advisory/consultancy is a plus

Own visa is a plus

Interested candidates can send their resume to

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 Manager role at NicheHR Global. Based in UAE.

• Regulatory Compliance: Oversee and manage regulatory activities related to core healthcare products, ensuring compliance with applicable laws and regulations. Interact with Production and Development teams to maintain product supply and help introduce new products. Assess product specifications of the company and its suppliers against customer requirements and government agencies.
• Liaise with auditors and ensure corrective actions and ongoing regulatory compliance.
• Lead regulatory submissions, including preparing and reviewing documents for product registrations and approvals. Ensure no new product is placed on FDA import alerts from legitimate shipments. Maintain all document dossiers for regulatory submissions.
• Serve as primary point of contact for regulatory agencies, building positive relationships to facilitate approvals and compliance.
• Provide expert guidance on US detention regulations and ensure adherence to quality standards across the organization.
• Collaborate cross-functionally with R&D, Quality Assurance, and Legal to integrate regulatory requirements into product development processes.
• Stay abreast of regulatory changes and industry trends; communicate updates to relevant stakeholders.
• Conduct internal audits to assess and enhance regulatory compliance and quality assurance processes.
• Assist in developing and implementing regulatory strategies to support product launches and lifecycle management.

Develop the yearly budget and adhere to it throughout the year in the business context and company profitability.

• Lead and coordinate staff across disciplines to plan, formulate and implement comprehensive regulatory requirements and procedures; foster positive relationships with external agencies.

Experience : Minimum of 12-13 years of progressive experience in core Healthcare Regulatory Affairs, with specific expertise in US detention regulations and Quality compliance. Strong understanding of regulatory requirements for healthcare products in overseas markets (e.g., GCC, EU, UK, USA, Canada, CIS, Trinidad & Tobago, Guatemala, Brazil, Kenya, Russia, Egypt, Uganda, Sudan, Malaysia, Mauritius, Vietnam, Turkey, Yemen, etc.).

Education : Master's degree in a relevant field (preferred M Pharma, M.Sc. Biotechnologist, Food Tech, etc.).

Skills : Excellent communication and interpersonal skills; ability to lead and collaborate within cross-functional teams; detail-oriented with strong organizational and project management abilities.

• Mid-Senior level

• Full-time

• Health Care Provider

• Personal Care Product Manufacturing
• Hospitals and Health Care

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

Job Opportunity

We are seeking a skilled Regulatory & Compliance Lawyer to work on a secondment basis for six months. The role is ideal for a mid-level lawyer with experience in trade sanctions, anti-bribery and corruption, and a strong interest in developing their career in ethics and compliance.

Key Responsibilities:

• Provide legal and regulatory advice on trade sanctions, anti-bribery, and anti-corruption matters.
• Support the development and implementation of ethics and compliance programmes across the business.
• Advise on regulatory risks and assist in investigations, audits, and compliance reviews.
• Draft and review policies, procedures, and training materials to ensure compliance with international standards.
• Collaborate with business stakeholders to embed a culture of integrity and responsible business conduct.
• Support cross-border compliance projects across the GCC and international markets.

Requirements:

• Five or more years PQE, admitted in a recognized international jurisdiction.
• Experience advising on trade sanctions and/or anti-bribery and corruption laws.
• Strong drafting, advisory, and stakeholder management skills.
• Previous in-house or secondment experience advantageous but not required.
• Interest in transitioning into a broader ethics & compliance role.
• Regional GCC experience preferred but not essential.

This is an excellent opportunity for a mid-level lawyer looking to gain experience in regulatory and compliance.

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.

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.

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.