Regulatory Affairs Officer

Job description / Role

• Coordinate with project lead and stakeholders to assess and define projects scope, requirements and timelines for proper planning and execution.
• Act as a point of contact and communicate project status with countries.
• Coordinate with Logistics/ Supply Chain/ Labeling teams and manufacturing site to obtain valid artworks and implementation dates.
• Arrange and request all needed documents and certificates for files submission to Health Authorities.
• Prepare submission dossiers and publish eCTD as per countries requirements and regulations.
• Coordinate and follow-up with countries to ensure timely submission as per plan.
• Support countries in Health Authorities’ queries to secure speedy approvals.
• Update project trackers and proper archiving for documents and dossiers.
• Comply with all internal SOPs and trainings.
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regular follow up on the submitted files.
• Ensure timely submissions as well tightly manage deficiency responses. Priority will be given to the positive margin products.
• Feed the trackers provided by APTL/ group/ AGI with accurate information and provide them with input for any regulatory plan rolled out.
• Work with the regulatory affairs manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries.
• Work with the regulatory affairs manager to develop and execute regulatory plans for complex projects including transfer of the newly acquired products, tech transfers and maintenance of licenses/authorizations for existing marketing authorizations.
• Work on Renewals (products and sites) submit the request as per the date mentioned in the renewal tracker. Renewal planned submission date should be met.
• Coordinate Regulatory Affairs filing for all Aramed Group Products.
- Submission and follow up on the current applications with MOHAP
- Regulatory concerns to be addressed and reported whenever required.
- Maintaining periodic updates on the changes from supplier(s)
- Visiting MOHAP, Dubai Municipality and relevant offices for their direct influence on company concerns.
- Notification sharing to regional team and to record their response to queries.
- Assist in Professional license renewals and facility license renewal with MOHAP
- Communicate and build relations with Key officials in Government department of RA for a smooth processing.
- Maintain Report on Submission and track updating on daily basis.
- Submit reports to Manager on monthly basis

Salary:
OMR 800 to 1,000 per month inclusive of fixed allowances.

Requirements

• Bachelor's degree in Science
• Mandatory experience in Regulatory affairs - derma/aesthetic
• Mandatory Arabic speaker
• Preference with the driving license in Oman
• Strong people management skills
• High level of interpersonal skills
• Excellent planning, organising and prioritising skills
• Ability to make decisions
• Ability to use initiative
• Ability to implement and ensure compliance with company policies & procedures

About the Company

Arabian Medical Enterprises ARAMED LLC is specialized in the field of Medical Aesthetics, Alternative Laser Treatment and Advanced Medical Solution fields. ARAMED was established in 2003 in the UAE with the intention to expand to the GCC market. After achieving solid, and strategic development in the UAE market. Driven by a unique team of management, ARAMED is determined to become a market leader in all product lines and achieve growth by both intensive and integrative growth strategies. We are keen to become the source of trust and advice for this business field by implementing well-crafted marketing techniques and programs.

ARAMED is entering its 17th year of operation. Its products have been well received, and marketing will be key to the development of brand and product awareness as well as the growth of the customer base. ARAMED possesses fair information about the market and knows a good deal about the common attributes of the most prized customers. This information will be leveraged to better understand who is served, what their specific needs are, and how ARAMED can better communicate with them.