Senior Regulatory Affairs Officer - Bouskoura
Company sector : Pharmacy / Health
COMPANY :
Sothema, United Energies for Life.
Sothema is a Moroccan pharmaceutical laboratory, specializing in the manufacturing and marketing of medicines since 1976. With over 250 products manufactured, Sothema represents 35 international client laboratories among the world leaders in Research & Development.
With an industrial tool at the forefront of innovation, Sothema benefits from recognized expertise enabling it to be the sole producer of insulin and eye drops in Morocco, and to position itself as a leader in the manufacture of flexible bag serums and cephalosporins. Thanks to its sterile block units, Sothema also specializes in injectable pharmaceutical forms such as pre-filled syringes, ampoules, and injectable vials.
Its injectable factory is the largest in Africa. Sothema's activities are certified in compliance with international quality (ISO) and manufacturing (BPF and GMP) standards: France, Belgium, Holland, Germany, Portugal...
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
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