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Regulatory Affairs Officer, MilanRef: BBBH23298

Salary:€40000.00 - €50000.00 per annum

Added:12 Jun 2018

Region: Italy

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen for an experienced Regulatory Officer / Senior Officer to join a growing biopharma based in Milan, Italy. Within this role you will be the main point of contact for all local submissions to AIFA. An experienced candidate is required with the ability to project manage and lead submissions. As Part of the Corporate Regulatory Affairs team you will support all products in all markets across the business. In addition you will support the local affiliate management team. Responsibilities: - Preparation of documentation and submissions to Health authorities, including AIFA and Ministry of Health in compliance with current legislation to ensure efficient registration and maintenance of the registrations in accordance with business strategies. -Proactive management AIFA open issue monitor , collect and interpret and apply all relevant legislation, regulatory trends and regulatory guidelines in Italy and keep the Italian business up to date on national regulatory trends, risks and opportunities , provide advice to the business as necessary and assist plan of action.. Interface with AIFA and industrial trade association. - Maintaining and processing of local regulatory database - Responsibility to gather all the necessary materials to submit products to regulatory authorities globally - Professional and timely response to authorities' questions - Strict cooperation and synergy with Company SOP's - Reporting to the Corporate Regulatory Affairs Head, you'll be part of a multicultural cross functional team where diversity is very high both in terms of gender and in terms of nationality, where performance and achievement are the common ground to build growth. Requirements: - University degree in life scientific (preferably pharmacy or pharmaceutical chemistry) - At least 4-5 years of experience in healthcare companies in regulatory role dealing with medicines - Familiarity with AIFA procedure and timelines Familiarity with module 1-5 , able to t prepare the documentation for the layout of the variations, and the GAP analysis. - Good knowledge of Guidelines ICH/EU, Italian and EU drug legislation - Italian native and mother-toungue - Fluent English - Good written and verbal communication skills with the ability to effectively and precisely present data - Attention to details with proven ability to establish priorities & achieve results - Multitasking attitude and problem-solving approach - High quality and ethical standards For further details about this role, or other regulatory roles, please contact Tim Barratt on +44(0)1727 817626 or email a copy of your CV to

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