Regulatory Affairs Officer

Ghobash Group; Dubai; On-site; AED 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to oversee product registration and compliance. This role involves managing regulatory submissions, coordinating with stakeholders, and ensuring adherence to guidelines and best practices. The ideal candidate will possess a Bachelor's degree in Pharmacy and have a strong commitment to regulatory excellence. This is an exciting opportunity to contribute to the success of innovative projects in a dynamic environment, while ensuring the highest standards of compliance and quality are maintained.

Qualifications

• UAE National (Emirati) is a mandatory requirement.
• In-depth understanding of regulations and guidelines is essential.

Responsibilities

• Compile and submit product registration files ensuring accuracy.
• Manage project timelines and provide regular status updates.

Skills

Regulatory Affairs

Project Management

Attention to Detail

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.

Desired Candidate Profile

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.

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