Regulatory Affairs Officer - Emiratization Program

Ghobash Group; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading regulatory compliance firm in Dubai is seeking a Regulatory Affairs professional to manage product registration and compliance tasks. The role requires an Emirati national with a Bachelor's degree in pharmacy and entails coordinating regulatory submissions, monitoring projects, and ensuring adherence to compliance standards. Strong communication, organizational skills, and a commitment to excellence are essential in this highly regulated environment. This full-time position does not offer remote work.

Qualifications

• UAE National (Emirati) is mandatory.
• Excellent attention to detail, organizational and communication skills required.
• In-depth understanding of regulations and guidelines necessary.
• Ability to work independently and collaboratively within a team environment.

Responsibilities

• Compile and submit product registration files ensuring accuracy.
• Monitor and track registration progress coordinating with stakeholders.
• Maintain records of new product regulatory updates.
• Review and verify Arabic labels for compliance.
• Prepare and submit regulatory submissions on time.
• Manage project timelines and deliverables.
• Provide regular status updates and project reports.

Skills

Attention to detail

Organizational skills

Communication skills

Team collaboration

Regulatory compliance understanding

Education

Bachelor's degree in pharmacy

Job description

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 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.

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