Regulatory Affairs Officer - Emiratization Program

Arabian Ethicals Co. (ETHIX); Dubai; On-site; AED 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Affairs professional to oversee product registration processes and ensure compliance with regulatory standards. This role involves managing project timelines, coordinating with stakeholders, and maintaining up-to-date records of product registrations. The ideal candidate will possess a Bachelor's degree in Pharmacy and demonstrate exceptional attention to detail and organizational skills. Join a forward-thinking company committed to regulatory excellence and contribute to impactful projects that shape the future of the industry.

Qualifications

• UAE National (Emirati) is a mandatory requirement.
• Strong commitment to compliance and regulatory excellence.

Responsibilities

• Compile and submit product registration files ensuring accuracy.
• Manage project timelines and deliverables for regulatory submissions.

Skills

Regulatory Affairs

Attention to Detail

Organizational Skills

Communication Skills

Compliance Knowledge

Education

Bachelor's Degree in Pharmacy

Job description

• 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 follow-up 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 life-cycle 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.
• Bachelor’s degree in pharmacy.
• 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.

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.