29 Regulatory Affairs Specialist jobs in the United Arab Emirates

As a Regulatory Services Officer, you will play a crucial role in ensuring the

We are seeking a Legal and Compliance Officer to support our company's expansion into the European Union under the Markets in Crypto-Assets Regulation (MiCA).

The successful candidate will be responsible for assisting with end-to-end license applications and regulatory coordination across selected EU jurisdictions.

• Strong knowledge of MiCA regulations and ability to apply them effectively.
• Excellent communication skills to ensure seamless liaison with EU legal and compliance advisors.
• Ability to research and compare different EU jurisdictions to support optimal licensing strategy.
• Attention to detail to track regulatory updates under MiCA and ensure company alignment with supervisory expectations.

Responsibilities include supporting the full lifecycle of MiCA license applications, preparing internal materials aligned with MiCA requirements, and ensuring timely and accurate submissions.

Flexible work location based in Dubai or a relevant EU jurisdiction. We offer competitive remuneration packages that align with industry standards.

Grow professionally in a dynamic and innovative environment. Develop expertise in EU financial regulations and stay up-to-date with industry developments.

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits.

• The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams.

This position requires strong communication, collaboration, and coordination skills across technical and regulatory functions. The successful candidate will have a high level of accuracy, attention to detail, and document management capabilities.

A bachelor's or master's degree in pharmacy (preferred) and 2-5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry, are required.

Responsibilities include:

• 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.
• Support documentation requests for internal audits, inspections, and compliance reviews.

Benefits of this role include:

• Opportunity to work in a dynamic and fast-paced environment.
• Chance to develop and improve regulatory affairs skills.
• Collaborative team environment.

The Compliance Manager plays a vital role in ensuring our organization operates within legal and regulatory frameworks. Key responsibilities include developing and implementing compliance activities, reviewing company policies, and advising management on potential risks.

1. We are seeking an experienced professional to develop and oversee control systems to prevent or deal with all legal guidelines and internal policies.
2. This role involves identifying risks or non-conformity issues, drafting, modifying, and implementing company policies.
3. The successful candidate will monitor enforcement of standards and regulations while collaborating with various departments.
4. They must keep abreast of regulatory developments and evolving best practices in compliance control.

Qualifications & Skills:

1. A degree in Legal or related studies is essential.
2. At least 5 years of experience in a compliance officer role is required.
3. Good knowledge of legal requirements and procedures ideally within the trading or FMCG industry is necessary.
4. Good knowledge of Food Manufacturing industry standards and regulations is also required.

We are seeking a highly skilled Regulatory Affairs professional to join our team. As a key member of our regulatory group, you will play a vital role in ensuring compliance with all relevant regulations and laws.

The successful candidate will be responsible for preparing regulatory submissions, managing artwork using specialized tools, updating and monitoring regulatory activities in databases, and maintaining regulatory compliance for products. Additionally, they will collaborate with the company to maintain a safe and compliant workplace.

• Bachelor's degree in Pharmacy, Medicine, Veterinary Science, or Life Sciences.
• 3-4 years of experience in Regulatory Affairs or Quality Assurance, preferably in the pharmaceutical industry.
• Proven project management experience within the pharmaceutical industry.

Benefits:

• Employee benefits as per UAE Labour Law.

1. Prepare regulatory submissions, including labeling, CMC, administrative sections, renewals, annual reports, and site registrations.
2. Manage artworks using Vista and VistaVac tools.
3. Update and monitor regulatory activities in databases such as Veeva Vault.
4. Prepare administrative documents related to PoA and CPP.
5. Maintain accurate translations of documents in compliance with Health Authority requirements.
6. Maintain regulatory compliance for products according to country-specific requirements.
7. Adhere to internal and external procedures and tools.
8. Collaborate with the company to maintain a safe and compliant workplace.

As a key member of our Regulatory Affairs team, you will play a crucial role in ensuring our products meet the highest standards of quality and safety.

This position involves entering data from various source documents into our computer system for processing on regulatory authorities' online systems related to suppliers and products. You will also prepare source data for computer entry by compiling and sorting information from regulatory documents such as ingredients lists/excel sheets prepared by brands.

You will be responsible for establishing entry priorities from brands and suppliers, entering data in the online systems by inputting alphabetic and numeric information according to screen format, maintaining data entry requirements/comply with data integrity, checking completed work for accuracy, leading times for product notifications, storing completed documents in designed locations, and maintaining the registration tracking files with certificates numbers and validity dates.

You will assist in labelling and artwork creation, including exchanges with brands. This role requires strong analytical and problem-solving skills, attention to detail, and ability to work independently and collaboratively as part of a team.

• Bachelor's degree in science, pharmacy, or regulatory affairs
• 1-2 years of experience in regulatory affairs and cosmetic industry, preferably in retail or FMCG
• Proficiency in planning tools (RELEX, SAP, Oracle, etc.) and Microsoft Excel/Power BI
• Strong communication, cross-functional collaboration, and stakeholder management skills
• Data input, ownership, and execution focus
• Collaborative communication skills

• We value authenticity and celebrate diversity and inclusivity
• We have a culture of empowerment where learning & growth is encouraged, offering opportunities to innovate and lead
• We strive to delight clients and inspire the industry every day

The Compliance Manager will assist in achieving the

Regulatory Affairs Specialist

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for managing regulatory activities required at a country level for pharmaceutical products, ensuring regulatory compliance in the applicable market(s).

This role involves working closely with global pharmaceutical companies to manage regulatory submissions, submit applications and follow-ups, and prepare product labelling.

Main Responsibilities:

• Manage Regulatory Submissions
• Submit Applications and Follow-ups
• Product Labelling Preparation
• Artwork Review and Approval
• Multiple Product Management
• Subject Matter Expertise
• Team Leadership
• Customer Relationships
• Regulatory Knowledge
• Project Budget Management
• Mentorship and Training
• Presentation and Communication
• Regulatory Standard Operating Procedures Review

Requirements:

• Typically requires 8-10 years of prior relevant experience.
• Masters Degree in Life Sciences or related discipline.
• 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.

We are seeking a detail-oriented and proactive regulatory affairs professional to support regulatory activities at our UAE-based manufacturing facility.

This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits.

The ideal candidate will collaborate closely with quality assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams.

• Compile and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.
• Evaluate accuracy, completeness, and regulatory compliance of all documentation submitted.
• Review artwork prior to submission to ensure correctness and regulatory alignment.
• Serve as liaison between regional regulatory teams and site-based technical functions.
• Coordinate responses to queries from health authorities during or post submission through regional RA teams.
• Maintain an organized archive of all regulatory submissions made from the site.
• Implement version control, submission tracking, and document retrieval protocols.
• Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.

• Bachelor's or master's degree in pharmacy (preferred).
• 2-5 years of experience in regulatory affairs, preferably in a manufacturing or site-based setting within the pharmaceutical industry.
• Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies is preferred.
• Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation is required.

• Strong communication, collaboration, and coordination skills across technical and regulatory functions.
• High level of accuracy, attention to detail, and document management capabilities.
• Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.
• Proactive approach to problem-solving and handling regulatory queries.

Dubai, United Arab Emirates