31 Regulatory Affairs Manager jobs in Dubai

Job Description

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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

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.

We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a vital role in ensuring the accuracy and completeness of product registration files.

• You will compile complete and submit product registration files, monitoring and tracking the progress of registration activities to expedite the approval process.
• Maintain records of new product regulatory updates and the validity periods of existing product registrations.

Key Responsibilities:

• Serve as the designated Regulatory Affairs representative for assigned regulatory projects.
• Prepare and submit lifecycle maintenance regulatory submissions in a timely and compliant manner.
• Manage project timelines deliverables and ensure alignment with both regulatory and business requirements.
• Provide regular status updates and project reports to management.

Qualifications and Requirements:

• UAE National (Emirati) is a mandatory requirement.
• Bachelor's degree in pharmacy or related field.
• Excellent attention to detail organizational and communication skills.
• In-depth understanding of regulations and guidelines.
• Ability to work independently and collaboratively within a team environment.
• Strong commitment to compliance quality and regulatory excellence.

Benefits:

• Opportunity to work on exciting regulatory projects.
• Professional development training and knowledge enhancement activities.

What We Offer:

A challenging and rewarding career opportunity in a dynamic environment. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Product Registration:

• Compile complete and submit product registration files ensuring the accuracy and completeness of all required documentation.
• Monitor and track the progress of registration activities coordinating with relevant stakeholders to expedite the approval process and ensuring timely followup until final approval is obtained.
• Maintain records of new product regulatory updates and the validity periods of existing product registrations.
• Review and verify Arabic labels to ensure accuracy and compliance with regulatory requirements.

Regulatory Project Management:

• Serve as the designated Regulatory Affairs representative for assigned regulatory projects.
• Prepare and submit lifecycle maintenance regulatory submissions in a timely and compliant manner.
• Manage project timelines deliverables and ensure alignment with both regulatory and business requirements.
• Provide regular status updates and project reports to management.

Compliance and Best Practice:

• Perform all responsibilities in accordance with current regulatory legislation guidelines and best practices.
• Ensure adherence to internal policies and quality standards across all regulatory activities.

Qualifications :

Qualifications and Requirements:

• UAE National (Emirati) is a mandatory requirement.
• Bachelors degree in pharmacy.
• Excellent attention to detail organizational and communication skills.
• Indepth understanding of regulations and guidelines.
• Ability to work independently and collaboratively within a team environment.
• Strong commitment to compliance quality and regulatory excellence.

ree or Higher

Additional Information :

• Perform any additional tasks and responsibilities as assigned by the Regulatory Affairs Manager.
• Actively engage in ongoing professional development training and knowledge enhancement activities.

Remote Work :

No

Employment Type :

Fulltime

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.