Regulatory Affairs Officer

Job description

Medicair Bioscience Laboratories S.A., a rapidly growing company, manufacturer and distributor of generic medicines, is currently seeking to recruit a Regulatory Affairs Officer, who will support regulatory activities for the licensing and distribution of our products as well as the day-to-day support in regulatory requests by the Department’s Director.

Main Responsibilities

RA activities

• Provide regulatory support for the submission of MAA to health authorities, especially Module 1 and administrative requirements
• Maintain the existing product portfolio, including submission of variation and renewal applications
• Support communication with regulatory authorities and clients
• Supports the Regulatory Affairs Department on various daily administrative tasks (Product Information updates, labelling, mock-ups, CPPs etc)
• Monitors the compliance regulatory landscape or emerging changes in legislation, regulation, guidelines, directives and international standards that Medicair needs to comply with
• Keeps up-to-date the Regulatory documentation repository

Pharmacovigilance Activities:

• ADR reviewing, processing and reporting to Eudravigilance database.
• Entering medicinal product information in XEVMPD
• Global and local literature screening 

Candidate Profile

• Bachelor’s degree or equivalent preferably in a scientific or related field
• Previous working experience in Regulatory or Pharmacovigilance activities will be considered an asset
• Good knowledge of Microsoft’s suite
• Fluent in English both written and verbal
• Team player with learning and growth mindset
• Strong organizational skills
• Attention to detail
• Ability to work on multiple projects

Compensation & Benefits

• Competitive salary
• Development opportunities
• Excellent learning opportunities, within a dynamic and multinational working environment
• Company PC 
• Private Health Insurance