Regulatory Affairs Specialist

Job Description

Description

Medica Group, a Partner of choice for aesthetic medicine solutions technologies. We represent the leading companies in the world of Aesthetic, Medical equipment and Skin Products in MENA and Southeast Asia.

We hire talented people who can thrive on responsibility, develop, and grow their career.

Role Summary

The Regulatory Affairs Specialist will be responsible to ensure the legality of all MEDICA's portfolio by receiving required approvals from concerned legal entities.

• Take charge of the new registration of the products.
• Oversee the renewal of registration.
• Organize files to meet the requirements of the health authority.
• Coordinate with suppliers to obtain necessary documents.
• Establish and maintain communication with doctors at the health authority to develop business relationships.
• Assist sales and medical representatives by providing copies of registration.
• Support procurement by facilitating shipment clearance.
• Ensure quality control by documenting product defects.
• Facilitate product registration for sub-distributors.
• Obtain import permits for machines.
• Follow up with all concerned parties to track shipment progress and obtain necessary approvals.
• Perform additional duties as assigned by management.
• Prepare regulatory dossiers, manage registration of labeling changes, and submit applications for new product launches to prevent delays.
• Collaborate closely with governmental authorities to maintain import permits and entity legal licenses from agencies such as Dubai Municipality, Ministry of Health, and Federal Authority for Nuclear Regulation.
• Maintain updated local archives for manufacturing site information, variations, and renewals, while monitoring regulatory activity with local distributors.
• Coordinate closely with internal stakeholders (such as sub-distributors) and other external parties.

• Bachelor's Degree in Pharmacy
• MOH and DHA License is a highly required.
• Computer Savvy to move around the Online Portal
• Knowledgeable of MS Office package
• Must be Arabic speaker with excellent English communication skills both written and verbally.
• Well-versed with relevant government sectors procedures and law
• Sound knowledge of documentation.

• At least with 2 years experience in the same role or as a pharmacist with the specific licenses ( Drug Store ).