PSenior Manager Regulatory Affairs (m / w / d) - Medicinal Products /ppOmniVision GmbH is an expanding medium-sized ophthalmology company with its headquarters in Germany and locations in Austria, Italy, Spain and Switzerland. In Germany, OmniVision GmbH is one of the leading non-corporate ophthalmology companies. Our product portfolio includes pharmaceuticals, medical devices and nutritional supplements. /ppIn the course of our strong growth, we are looking for a committed and motivated person to join our headquarters in Puchheim near Munich as soon as possible : /ppbYour Profile : /b /pulliUniversity degree in natural sciences, preferably Pharmacy, Biology or Chemistry /liliAt least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU /liliExperience in creating eCTD sequences /liliOpen-minded personality /liliAbility to lead a team /liliService-orientation /liliAbility to grasp things quickly, analytical thinking in combination with an independent, structured and goal-oriented way of working /liliProactive thinking and acting, assertiveness, flexibility and strong communication skills /liliFluent in German and English with excellent oral and written communication skills /liliIT affinity : eCTD, databases, Regulatory Information Management Systems (RIMS), Microsoft Office suite /li /ulpbYour contribution : /b /pulliPlanning and submission of national change notifications and EU-variations to competent authorities /liliCompilation of variation packages regarding quality (CMC) and product information aspects /liliPlanning and submission of renewal applications /liliManagement of national and European variation and renewal procedures /liliCommunication with European competent authorities (EU and Switzerland) /liliAnswering letters of deficiency (List of Questions (LoQs)) /liliProcurement and assessment of documents from international suppliers (Contract Manufacturing Organizations (CMOs)) /liliCreation and revision of product information texts (SmPC, PIL, labelling) for the implementation of officially requested text amendments and / or for text adaptations to the current state of knowledge /liliCoordination of all regulatory lifecycle management activities in the OmniVision subsidiaries (Austria, Italy, Spain and Switzerland) /liliCreation of eCTD sequences for the submission of variation and renewal applications /liliMaintaining and updating the company's internal marketing authorization database /liliCollaboration in the company's internal change control process /liliMonitoring, interpretation and implementation of new regulatory requirements /li /ulpbWe offer you : /b /pulliPermanent, long-term employment in a successful, owner-operated medium-sized pharmaceutical company /liliAn attractive compensation package /lili30 days of annual vacation /liliFlexible working hours including remote work options /liliModern IT infrastructure /liliModern and air-conditioned offices /liliErgonomic workstations /liliSubsidized company pension plan /liliFinancial support for job bikes (company bicycle program) /liliCoverage of the "Deutschlandticket" (nationwide public transportation ticket) /liliSubsidized lunch including free beverages /liliSeasonal fruit basket /liliCompany events /liliEGYM Wellpass /liliOnline employee discount portal via Corporate Benefits /li /ulpbDoes this sound interesting to you? /b /ppWe look forward to receiving your application (cover letter stating your salary expectations and earliest possible starting date, CV and references) to the attention of Francisco Lopez, HR Manager. /ppJ-18808-Ljbffr /ppJ-18808-Ljbffr /ppSenior Product Manager • Abruzzo, Pescara, Italia /p #J-18808-Ljbffr