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