Ra Sr. Specialist 1

Julphar; United Arab Emirates; On-site; AED 240,000 - 320,000; Full time

Job summary

Julphar seeks a Regulatory Affairs professional to manage compilation and submission of new registration dossiers to health authorities across countries. You will handle queries, coordinate with internal teams, and ensure documentation meets all requirements.

The candidate should hold a Bachelor of Pharmacy/Science with at least 4 years of experience, be proficient in MS Office and Adobe Pro, and possess CTD/eCTD knowledge.

Qualifications

• Bachelor of Pharmacy/Science with minimum 4 years of experience.
• Proficient in MS Office and Adobe Pro.
• Strong CTD/eCTD dossier knowledge.

Responsibilities

• Responsible for compilation and submission of new registration dossiers to respective countries as per the registration plan.
• Handle queries to obtain approvals from health authorities of different countries.
• Evaluate and identify documentation gaps during dossier compilation and coordinate with departments to fulfill requirements.

Skills

Regulatory submissions

English communication

MS Office

Adobe Pro

Education

Bachelor of Pharmacy/Science

Tools

CTD/eCTD knowledge

Job description

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Detailed Job Description

• Responsible for compilation and submission of new registration dossiers to respective countries as per the registration plan.
• Handle the queries by providing the appropriate responses, as it is required to get the approvals from the health authorities of different countries.
• Evaluation and identification of documentation gaps during the dossier compilation and communicating with the respective department to fulfil requirements.

Core Competency

• Excellent in Result & Process Orientation for department target achievement.
• Responsible in approach, high on Accountability & Ownership.
• Excellent team building, strong time and task management.
• Excellent oral and written communication skills in English.
• Highly disciplined, motivated and organized.
• Open for new learnings and leading the learning implementation at the workplace.
• Follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
• Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
• Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiatives.

Qualification/Functional Knowledge

• Bachelor of Pharmacy / Science graduate with min 4 years of experience.
• MS Office and Adobe Proficient.
• Excellent scientific & technical knowledge for dossier compilation in CTD and eCTD format.

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