PDevelop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization. /ppRegulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant government legislation, and that patient safety and efficacy are at the forefront of business activities. Act as the critical liaison between their organisation, the products they sell and the regulatory authorities by applying their scientific, business and regulatory expertise. /ppbMain activities : /b /ppManage the registration of pharmaceutical products, as well as medical devices and API in your countries and regions. /ppSupport the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals) /ppProvide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation /ppAssist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines /ppAct as liaison between multiple project teams to obtain significant information as well as answer queries that may arise /ppCommunicate design changes to existing products and company practices where necessary /ppPlan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals /ppStay up to date with the latest rules and regulations /ppbGive presentations to regulatory authorities /b /ppWrite appropriate standard harmonised regulatory affairs operating procedures for the company /ppbCoordinate local compliance activities : /b /ppimpact assessment on local Change Control, define the local regulatory strategy for drug product communications, in compliance with local regulation. /ppbRequirements : /b /ppBachelor Degree in Life Science disciplines, preferably in Pharmacy / CTF / Biological Sciences / Chemistry. A specialisation in Regulatory Affairs is a plus. /ppAt least 5 years experience in regulatory field within pharmaceutical industry, preferably in companies with manufacturing sites for medical products /ppKnowledge of medicines legislation, GMP and reference guidelines. /ppExperience with AIFA and AGES is prefered. /ppExperience in using the various applications of the AIFA portal. /ppbGood communication skills – both written and verbal /b /ppSkills of team working, critical thinking and planning, meeting deadlines efficiently. /ppbThe ability to work under pressure and to tight deadlines /b /ppFluent in both spoken and written English. Fluency in another major European language is preferred. /ppRegulatory Affair • Bregnano, Lombardia, Italia /p #J-18808-Ljbffr