40 Regulatory Affairs Manager jobs in the United Arab Emirates

Job Description

We are NTS Group.

The regions leading Executive Search Outplacement & Career Transition firm across the Middle East bringing over 25 years of local expertise and a track record of exceptional service for our clients and candidates. Operating from our strategically positioned offices in Dubai London and Singapore we offer a comprehensive range of services delivered by industry experts. These include Contingency & Executive Search Campaigns Outplacement & Redundancy Support RPO Projects Talent Mapping Women in Leadership & Leadership Development and our awardwinning Executive Career Transitioning Programs.

We are currently working with a leading global Healthcare company to recruit aRegulatory Affairs Manager based in the UAE. This position will be responsible for overseeing the regulatory affairs function ensuring compliance with local and international regulations and supporting the companys strategic business objectives.

What Youll be Doing

• Leading the regulatory affairs team to ensure effective management of product registrations variations renewals and compliance processes.
• Developing and executing regulatory strategies to support new product launches market access and lifecycle management of the portfolio.
• Acting as the primary point of contact with UAE health authorities such as the Ministry of Health to manage regulatory submissions and resolve queries.
• Monitoring interpreting and implementing changes in local and international regulations ensuring the business remains compliant and informed.
• Collaborating with crossfunctional teams including R&D marketing supply chain and legal to align regulatory processes with business goals.
• Overseeing the preparation review and submission of regulatory dossiers and related documentation.
• Establishing and maintaining robust systems for regulatory documentation reporting and compliance tracking.
• Providing regulatory advice and training to internal stakeholders to enhance organizational awareness and compliance standards.

Who You Are

• Bachelors degree in Pharmacy Life Sciences or a related field (Masters degree is preferred).
• 6 years of experience in Regulatory Affairs within the healthcare industry including at least 2 years in a managerial or leadership role.
• Comprehensive knowledge of UAE and GCC regulatory guidelines as well as international standards (e.g. ICH WHO).
• Proven experience in managing regulatory submissions approvals and compliance frameworks.
• Strong leadership and team management skills with the ability to mentor and develop talent.
• Excellent communication and interpersonal skills capable of building strong relationships with health authorities and internal stakeholders.
• High attention to detail organizational skills and the ability to manage complex projects and multiple priorities.
• Proficiency in Microsoft Office and regulatory management systems.

Due to the large number of applications we receive we can only respond to candidates who have been shortlisted for the position. If you havent had a response within 5 working days please assume you have not been shortlisted. Many thanks and good luck in your job search.

Required Experience:

Manager

Job Description

We are NTS Group.

The regions leading Executive Search Outplacement & Career Transition firm across the Middle East bringing over 25 years of local expertise and a track record of exceptional service for our clients and candidates. Operating from our strategically positioned offices in Dubai London and Singapore we offer a comprehensive range of services delivered by industry experts. These include Contingency & Executive Search Campaigns Outplacement & Redundancy Support RPO Projects Talent Mapping Women in Leadership & Leadership Development and our awardwinning Executive Career Transitioning Programs.

We are currently working with a leading global Healthcare company to recruit aRegulatory Affairs Manager based in the UAE. This position will be responsible for overseeing the regulatory affairs function ensuring compliance with local and international regulations and supporting the companys strategic business objectives.

What Youll be Doing

• Leading the regulatory affairs team to ensure effective management of product registrations variations renewals and compliance processes.
• Developing and executing regulatory strategies to support new product launches market access and lifecycle management of the portfolio.
• Acting as the primary point of contact with UAE health authorities such as the Ministry of Health to manage regulatory submissions and resolve queries.
• Monitoring interpreting and implementing changes in local and international regulations ensuring the business remains compliant and informed.
• Collaborating with crossfunctional teams including R&D marketing supply chain and legal to align regulatory processes with business goals.
• Overseeing the preparation review and submission of regulatory dossiers and related documentation.
• Establishing and maintaining robust systems for regulatory documentation reporting and compliance tracking.
• Providing regulatory advice and training to internal stakeholders to enhance organizational awareness and compliance standards.

Who You Are

• Bachelors degree in Pharmacy Life Sciences or a related field (Masters degree is preferred).
• 6 years of experience in Regulatory Affairs within the healthcare industry including at least 2 years in a managerial or leadership role.
• Comprehensive knowledge of UAE and GCC regulatory guidelines as well as international standards (e.g. ICH WHO).
• Proven experience in managing regulatory submissions approvals and compliance frameworks.
• Strong leadership and team management skills with the ability to mentor and develop talent.
• Excellent communication and interpersonal skills capable of building strong relationships with health authorities and internal stakeholders.
• High attention to detail organizational skills and the ability to manage complex projects and multiple priorities.
• Proficiency in Microsoft Office and regulatory management systems.

Due to the large number of applications we receive we can only respond to candidates who have been shortlisted for the position. If you havent had a response within 5 working days please assume you have not been shortlisted. Many thanks and good luck in your job search.

Required Experience:

Manager

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

No Relocation Assistance Offered
#99193 Dubai Dubai United Arab Emirates

Emirati Dirham

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity sexual orientation national origin ethnicity age disability marital status veteran status (United States positions) or any other characteristic protected by law.

Are you interested in working for ColgatePalmolive You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by email are not considered in the selection process. Become part of our team. We look forward to your application.

ColgatePalmolive is a leading global consumer products company tightly focused on Oral Care Personal Care Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate Palmolive elmex Toms of Maine Sorriso Speed Stick Lady Speed Stick Softsoap Irish Spring Protex Sanex Elta MD PCA Skin Ajax Axion Fabuloso Soupline and Suavitel as well as Hills Science Diet and Hills Prescription Diet.

For more information about Colgates global business visit the Companys web site at . To learn more about Colgate Bright Smiles Bright Futures oral health education program please visit . To learn more about Hills and the Hills Food Shelter & Love program please visit . To learn more about Toms of Maine please visit .

Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject Accommodation Request should you require accommodation.

Required Experience:

Manager

No Relocation Assistance Offered
#99193 Dubai Dubai United Arab Emirates

Emirati Dirham

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity sexual orientation national origin ethnicity age disability marital status veteran status (United States positions) or any other characteristic protected by law.

Are you interested in working for ColgatePalmolive You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by email are not considered in the selection process. Become part of our team. We look forward to your application.

ColgatePalmolive is a leading global consumer products company tightly focused on Oral Care Personal Care Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate Palmolive elmex Toms of Maine Sorriso Speed Stick Lady Speed Stick Softsoap Irish Spring Protex Sanex Elta MD PCA Skin Ajax Axion Fabuloso Soupline and Suavitel as well as Hills Science Diet and Hills Prescription Diet.

For more information about Colgates global business visit the Companys web site at . To learn more about Colgate Bright Smiles Bright Futures oral health education program please visit . To learn more about Hills and the Hills Food Shelter & Love program please visit . To learn more about Toms of Maine please visit .

Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject Accommodation Request should you require accommodation.

Required Experience:

Manager

No visa or accommodation sponsorship

You 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 OVERVIEW

Essential Functions

1. Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
2. 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.
3. Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.
4. Artwork review and approval in client systems.
5. Manage multiple pharmaceutical products.
6. Act as subject matter expert in regulatory processes.
7. Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.
8. Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.
9. Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers / Labeling/ Publishing.
10. Project budget management.
11. Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.
12. Possible exposure to present to clients on complex regulatory processes and bid defense meetings.
13. Act as reviewer for regulatory standard operating procedures.
14. Prepare and deliver internal regulatory training if required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Experience: Typically requires 8-10 years of prior relevant experience.

Education: Masters Degree in Life Sciences or related discipline.

Skills and Abilities:

• Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.
• Possesses specific regulatory or technical expertise.
• Interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Demonstrates self-motivation and enthusiasm.
• Ability to adapt quickly to a rapidly changing environment.
• Knowledge of Maintenance of Marketing Authorization.
• Experience of preparing variation renewal packages and artwork approvals.
• Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.
• Must be fluent in Arabic.

#LIRemote

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

No visa or accommodation sponsorship

You 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 OVERVIEW

Essential Functions

• Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
• 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.
• Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.
• Artwork review and approval in client systems.
• Manage multiple pharmaceutical products.
• Act as subject matter expert in regulatory processes.
• Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.
• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.
• Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
• Project budget management.
• Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.
• Possible exposure to present to clients on complex regulatory processes and bid defense meetings.
• Act as reviewer for regulatory standard operating procedures.
• Prepare and deliver internal regulatory training if required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Experience: Typically requires 8-10 years of prior relevant experience.

Education: Masters Degree in Life Sciences or related discipline.

Skills and Abilities:

• Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.
• Possesses specific regulatory or technical expertise.
• Interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Demonstrates self-motivation and enthusiasm.
• Ability to adapt quickly to a rapidly changing environment.
• Knowledge of Maintenance of Marketing Authorization.
• Experience of preparing variation renewal packages and artwork approvals.
• Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.
• Must be fluent in Arabic.

#LIRemote

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

• Graduate of an accredited Bachelor's degree Nursing program
• Current Registered Nurse (RN) license
• Maintains Basic Life Support (BLS) competency
• Minimum of two years previous RN experience in ambulatory and / or acute care settings
• Certification from an appropriate accredited certifying body (e.g., ACRP or SOCRA) is strongly preferred.
• Specialist Certifications: N.A.
• Experience
• Extensive knowledge of research study design, development, artificial intelligence, and disease process is preferred.
• At least three years of related research experience in a healthcare institution.
• At least four years of experience as a registered nurse.
• Five years of experience in clinical research and conducting clinical trials and / or clinical studies.
• Candidates must be graduates of an accredited nursing program with a current RN license and at least four years of nursing experience.
• Certification in clinical research is preferred, along with extensive knowledge of research study design and at least three years of related research experience.

Registered Nurse - Clinical Research Coordinator (RN-CRC) role at Sheikh Shakhbout Medical City - SSMC. The RN-CRC is accountable for managing and/or participating in all phases of the research process, supports professional nursing practice across practice settings and the continuum of care to meet the needs of the research participant and family, advocates for human subject rights, and coordinates participant/family education in the clinical research setting. Work is primarily self-directed with guidance from staff physicians and/or principal investigators. The RN-CRC participates in organizing and monitoring protocols, staff education in protocol areas, and coordinates study data collection, storage, retrieval, and related procedures to comply with local and international regulatory laws and institutional guidelines.

• Collects and reviews health data in a comprehensive and systematic format by assessing, observing, and evaluating a patient/family based on established guidelines and protocols.
• Assesses patient/family educational needs and readiness to learn, considering age-related factors and using appropriate resources.
• Uses communication techniques appropriate to the patient/family’s age and abilities.
• Interprets assessment data to reflect the patient’s status and documents relevant data in a retrievable form.
• Develops and documents the plan of care, including continuity of care with the patient, family, and health team members.
• Implements the plan of care in collaboration with the health care team and conducts patient and family teaching consistently.
• Performs treatments and procedures according to research protocol guidelines and maintains a safe, clean, and organized environment.
• Applies asepsis and infection control principles; documents actions, outcomes, and future plans.
• Provides ongoing evaluation of patient progress toward research outcomes and involves the patient, family, and health care team in the evaluation process.
• Makes ethical decisions and acts as a patient advocate, respecting privacy, dignity, personal preferences, and culture.
• Reviews protocol, develops budget justifications, determines feasibility, and interfaces with investigators and sponsors to initiate protocol and draft budgets.
• Develops and conducts training for staff responsible for non-nursing protocol procedures and participates in study meetings as required.
• Develops effective screening tools and patient eligibility processes and coordinates recruitment activities according to approved procedures.
• Ensures protocol compliance, reports adverse events to IRB and principal investigator/sponsor, and maintains accurate documentation and drug/device accountability as required.

• Required: Bachelor’s degree in nursing from an accredited program; current Registered Nurse (RN) license; Basic Life Support (BLS) competency; minimum of two years RN experience in ambulatory and/or acute care settings.
• Desirable: Certification from an accredited body (e.g., ACRP or SOCRA) is strongly preferred.
• Required: Extensive knowledge of research study design, development, disease processes, and at least three years of related research experience in a healthcare institution; at least four years of experience as a registered nurse.
• Desirable: More than five years of experience in clinical research and conducting clinical trials.
  

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Health Care Provider
• Industries: Hospitals and Health Care