Senior Manager Regulatory Affairs (m / w / d) - Medicinal ProductsOmniVision 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.In 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 :Your Profile :University degree in natural sciences, preferably Pharmacy, Biology or ChemistryAt least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EUExperience in creating eCTD sequencesOpen-minded personalityAbility to lead a teamService-orientationAbility to grasp things quickly, analytical thinking in combination with an independent, structured and goal-oriented way of workingProactive thinking and acting, assertiveness, flexibility and strong communication skillsFluent in German and English with excellent oral and written communication skillsIT affinity : eCTD, databases, Regulatory Information Management Systems (RIMS), Microsoft Office suiteYour contribution :Planning and submission of national change notifications and EU-variations to competent authoritiesCompilation of variation packages regarding quality (CMC) and product information aspectsPlanning and submission of renewal applicationsManagement of national and European variation and renewal proceduresCommunication with European competent authorities (EU and Switzerland)Answering letters of deficiency (List of Questions (LoQs))Procurement and assessment of documents from international suppliers (Contract Manufacturing Organizations (CMOs))Creation 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 knowledgeCoordination of all regulatory lifecycle management activities in the OmniVision subsidiaries (Austria, Italy, Spain and Switzerland)Creation of eCTD sequences for the submission of variation and renewal applicationsMaintaining and updating the company's internal marketing authorization databaseCollaboration in the company's internal change control processMonitoring, interpretation and implementation of new regulatory requirementsWe offer you :Permanent, long-term employment in a successful, owner-operated medium-sized pharmaceutical companyAn attractive compensation package30 days of annual vacationFlexible working hours including remote work optionsModern IT infrastructureModern and air-conditioned officesErgonomic workstationsSubsidized company pension planFinancial support for job bikes (company bicycle program)Coverage of the "Deutschlandticket" (nationwide public transportation ticket)Subsidized lunch including free beveragesSeasonal fruit basketCompany eventsEGYM WellpassOnline employee discount portal via Corporate BenefitsDoes this sound interesting to you?We 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.J-18808-Ljbffr
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