Zona: Oeiras
Data: 2023-10-27
Categoria: Regulatory Affairs Manager
Sector: Genérico
Pharmaplanet seeks a Regulatory Affairs Officer to integrate a renowned company in the Pharmaceutical Industry on a project expected to last 1 year (maternity leave).
•Provide clear, concise, timely, commercially focused regulatory advice to all business functions on regulatory matters
• Build and maintain a relationship with health authority on regulation, policy formulation and emerging regulatory developments
• Collaborate to ensure an aligned approach with the wider Regulatory Affairs team
• Lead in the preparation of submissions and regulatory strategy (monitor of registration procedure, maintenance of product and procedures registries)
• Advisory to QA on GMP and GMP issues
• Review and approve all new or revised artworks and promotional materials from different product categories
• Ensure compliance on PV company system
• Collection, assessment and reporting of all adverse events and adverse drug reactions to the Global Medical Affairs Group (Medicines Safety)
• Ensuring that all enquiries from authorities can be dealt with fully and in a timely manner
• Cooperation in the preparation of answers to requests of Medical Information
• Management of Quality complaints
• Maintenance of local SOPs
• Cooperation in sales force training
• Act as responsible deputy pharmacist (Technical Director/Qualified Person) and as contact person for government institutions and partners
• Support the activities of third parties regarding company products, ensuring that storage, handling, distribution, and labelling activities are in accordance with internal
procedures and with the requirements of national authorities, namely Good Distribution Practices (GDP)
• Master in Pharmaceutical Sciences (mandatory)
• At least 2 3 years technical experience in the regulatory/ quality space
• Analytical skills forecasting scenarios and making best practice recommendations
• Communication/presentation skills written and oral
• Collaborative approach
• Language Fluent in oral English
• Integration in a renowned company in the Pharmaceutical Industry;
• Possibility of professional development;
• Fixed remuneration
Local: Oeiras
Estimated project duration: 1 year
REF: RA_Officer
Please send your CV through our website pharmaplanet.pt