Pharmacist (m/w/d) (Pharmazeut/in)

OmniVision GmbH is a growing, mid-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements.Due to our strong growth, we are looking for a dedicated and motivatedManager Regulatory Affairs (m/f/d) - Medicinal Productsto join our headquarters in Puchheim near Munich as soon as possible.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 Organisations (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 knowledgeCreation of eCTD sequences for the submission of variation and renewal applicationsMaintaining and updating the company's internal marketing authorisation databaseCollaboration in the company's internal change control processMonitoring, interpretation and implementation of new regulatory requirementsUniversity degree in natural sciences, preferably Pharmacy, Biology or ChemistrySeveral years of professional and practical experience in regulatory affairs (medicinal products) within the EUExperience in creating eCTD sequencesAbility to work in a team, service-orientationQuick comprehension, 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, Microsoft Office suiteA permanent, long-term oriented position in a successful, owner-managed, mid-sized pharmaceutical companyAn attractive compensation packageOpportunities for further training and development30 days of annual leaveFlexible working hours, including mobile/remote workA modern IT infrastructureModern, air-conditioned officesErgonomic workstationsSubsidized company pension schemeFinancial support for a company bike (JobRad)Commuting allowanceSubsidized lunch, including free beveragesSeasonal fruit basketCompany eventsEGYM WellpassOnline portal for employee discounts via Corporate BenefitsHomeoffice:Umfang: Nach Vereinbarung