Entreprise
Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use — development, production, promotion, and marketing – with the mission to improve and preserve human life and the human health.
Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Morocco, Colombia, and Brazil) with a strong focus on expanding internationally and building strategic partnerships.
To strengthen our core team in Berrechid (Morocco), we are looking for a Regulatory Affairs Officer to join Atlas Pharm
Adresse
Zone Industrielle Berrechid route principale n°7 rue C
Poste
Responsibilities :
Responsible for registration dossier preparation and submission to HA according to the company’s strategy and planning
Responsible for maintenance activity (CMC, Labeling, administrative) dossier prepartion and submission to HA, according to the country regulations, requirements and the planning defined by RA Manager,
Responsible for dossier preparation for GMP request, tenders, and response to HA request
Ensure regulatory data bases and share point are up to date in timely manner
Ensure all the training are done according to the defined timeline
Create and maintain a good relationship with HA ; build trust
Ensure regulatory support for products shortage, discontinuation, recall,
Responsible to interact with health authorities and to follow regulatory submissions until approvals
negotiate with regulatory authorities
Develop regulatpry expertise and advise scientists and manufacturers on regulatory requirements
provide strategic advice to senior management throughout the development of a new product
Profile recherché
Skills
Scientific degree (bac+ 4)
understanding of both legal and scientific matters
the ability to assimilate and evaluate scientific data
analytical and problem-solving skills
written and oral communication skills
attention to detail
strong negotiation skills
Organizational skills and ability to work under pressure and to strict deadlines
the confidence to report to management
teamworking skills and the ability to lead and motivate others
Lnaguage : Fluent in french english & arabic
Experience :
2 years experience (at least) in regulatory affairs
Knowledge in regulatory requirements
Digital tool knowledge
