Regulatory Affairs Executive - Riyadh, المملكة العربية السعودية - Aramed

وصف

• 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 followup 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.
• 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
• Bachelor's degree in Science
• Mandatory experience in Regulatory affairs derma/aesthetic
• Mandatory Arabic speaker
• Preference with the driving license in KSA
• 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

• Muscat: Reliably commute or planning to relocate before starting work (required)

• Bachelor's (preferred)

• Pharmacists: 2 years (preferred)
• Pharmaceutical: 2 years (preferred)
• Medical Equipment's: 2 years (preferred)

• Arabic (preferred)

• Driving License (preferred)
• Pharmacist (preferred)