Senior Regulatory Affairs Officer | Bouskoura (Morocco)

Company culture :

Sothema operates within a performance-driven and competitive culture, where ambition, results orientation and customer focus are key priorities. This dynamic is closely balanced by a collaborative environment that promotes trust, teamwork and close leadership. The company also relies on a structured organization to ensure efficiency, quality and process consistency. An innovation component further complements this balance, supporting adaptability and continuous improvement.

Job :

As part of strengthening our Regulatory Affairs team, we are looking for a Senior Regulatory Affairs Officer.

Your main tasks:

• Participate in the preparation and administrative follow-up of health and pharmaceutical product registration files
• Manage regulatory requests related to narcotics and psychotropic substances
• Ensure the management of regulatory databases
• Ensure administrative follow-up of submissions, correspondence, and deadlines with health authorities
• Coordinate the preparation of responses and renewal files
• Ensure the submission of regulatory supplements in response to commitments made to health authorities.
• Ensure the management, filing, and archiving of regulatory dossiers
  

Required profile :

Profile sought:

• Bachelor's degree in science (Bac+4) or equivalent
• Minimum 5 years of experience in a similar role
• Good knowledge of marketing authorization files and regulatory processes
• Rigor, autonomy, initiative, and organizational skills
• Good command of computer tools, especially EXCEL
• Proficiency in French and good level of English