Head of Regulatory Affairs and Pharmacovigilance
CANNPRISMA is recruiting a Head of Regulatory Affairs and Pharmacovigilance, full time.
• Responsible for ensuring the correct management and approval of orders for new products and materials after document verification, proper registration in the market and materials, renew and keep up to date records and codifications, following the procedures established by the Competent Authorities and adopted by CANNPRISMA;
• Carry out all activities related to the registration of cannabis plant-based preparations, medicines, medical devices, cosmetic and body care products and food supplements, namely in the submission, management and filing of regulatory processes, in the monitoring and maintenance of the cycle of product life and ensuring regulatory compliance and compliance with applicable legislation throughout the process;
• Develop regulatory strategies, make contacts and collaborate with Competent Authorities and other Regulatory Entities, and carry out all activities within the scope of Pharmacovigilance and Surveillance of Health Products;
• Regulatory support and design of strategies for product registration in different markets/countries in accordance with local legislation and submission requirements in the exporting countries in which CANNPRISMA operate;
• Adaptation of the dossiers in accordance with the submission requirements of the exporting countries, their submission and maintenance of the respective marketing authorizations;
• Consolidated experience in the area of Pharmaceutical Regulation;
• Degree in Pharmaceutical Sciences, with specialization in Regulatory Affairs.
• English language (proficient);
• Experience in using ERP system;
• Knowledge of GMP standards;
• Good communication and negotiation skills;
• Analytical capacity, organized and systematic;
• Team spirit;
• Be proactive;
• Ease of interpersonal relationships;
• Results oriented;
• Ethical at work and with a positive team attitude;
• Good communication skills;
• Good multitasking and supervision skills;
• Priority management.
To apply, send your Curriculum Vitae with the subject “Head of Regulatory Affairs and Pharmacovigilance” to the email: firstname.lastname@example.org
Doubts and questions, should be sent to the same email.
Only candidates selected for interview will be contacted.