Regulatory and Marketing Manager
Bin Ali Medical Supplies
مجموع سنوات الخبرة :5 years, 10 أشهر
⮚ Spearheading the marketing efforts for non-registered medicines and CT contrasting agents, strategically driving market penetration and growth. ⮚ Ensuring regulatory compliance for marketed products, collaborating with regulatory bodies for streamlined processes. ⮚ Overseeing the registration of Medical Devices with the relevant Health Authorities in the UAE. ⮚ Maintaining meticulous records of registration documents, certificates, and ensuring timely renewals with health authorities. ⮚ Collaborating closely with MOH, DM & ESMA, manufacturers, and support services to ensure a seamless marketing process. ⮚ Leading internal working groups for packaging creation of newly acquired products. ⮚ Evaluating labeling, advertising, and promotional materials for regulatory compliance. ⮚ Ensuring strict adherence to organizational processes and quality protocols. ⮚ Managing the traceability of agency agreements with manufacturers, including their preparation and renewals. ⮚ Orchestrating marketing initiatives in compliance with regulatory requirements for regional markets through major exhibitions within the region. ⮚ Providing valuable regulatory intelligence to support the development and implementation of marketing and regulatory strategies. ⮚ Effectively addressing and responding to inquiries from regulatory agencies.
Key responsibilities
⮚ Manage and co- ordinate the registration of Manufacturing site and products with concerned Health Authority for UAE ⮚ Hands on experience with product registration to MOH, UAE, Dubai Municipality, ESMA for different range of products (medical devices, consumables, cosmetics). ⮚ Maintain the records of registration documents, copies of certificates and initiate the timely renewal of registrations with health authority. ⮚ Close coordination with MOH, DM & ESMA, manufacturers and other support services to ensure a smooth registration process.
⮚ Collaborated with internal working groups for packaging creation of newly acquired products. ⮚ Examine the Labeling, Advertising and Promotional materials with Regulatory compliance. ⮚ Assure strict adherence of processes to Quality protocol of the organization. ⮚ Trace the status of agency agreements with the manufacturers; involved in its preparation and their renewals. ⮚ Arrange and coordinate the regulatory requirements for the regional markets through major exhibitions within the region. ⮚ Co-ordinate with logistics dept. to obtain the import permits for the devices, GSL products and medicinal products for inward shipments and documents required for export of items to different zones. ⮚ Provide regulatory intelligence knowledge to support the development and implementation of regulatory and business. ⮚ Addressed and responded to questions from regulatory agencies.