Regulatory Affairs and Medical Associate

About the role

Aspen Holdings is hiring a Regulatory Affairs and Medical Associate in Riyadh on a permanent basis. The role covers regulatory and compliance tasks for the company's product lines, defines and communicates regulatory requirements internally, and engages healthcare professionals in non-promotional medical and scientific discussions about on-market and in-development products.

Key responsibilities

• Prepare and submit regulatory documents on time, follow up submitted files and manage deficiency responses, prioritizing products with a positive margin
• Keep regulatory trackers accurate and help build regulatory plans, including renewals of products and sites and maintenance of marketing authorizations
• Review and annotate labelling artwork against local guidelines and archive submitted dossiers
• Identify changes in the healthcare regulatory environment and share them with the right people
• Take part in selecting experts for research, education and advisory roles, and deliver scientific presentations to physicians and HCPs
• Support sales and marketing teams with scientific updates and act as a 24/7 point of contact for medical information
• Monitor promotion compliance in the territory and approve promotional material

Required profile

• Bachelor's degree in Pharmaceutical Sciences
• 3+ years of regulatory affairs experience in the pharmaceutical field
• Saudi nationality
• Advanced English writing and speaking, and advanced MS Office skills