Ph3Responsible Person (according to TPA/MLPO) Responsible Person for Advertising /h3 pCompany: B. Braun Medical AGbr/Job Posting Location: Sempach, Luzern, Switzerlandbr/Functional Area: Clinical/medical areabr/Working Model: Hybridbr/Requisition ID: 6606 /p pYou’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise. /p pAs a Swiss subsidiary of the globally active B. Braun Group, we are one of the market leaders in Switzerland and offer our more than 1,100 employees exciting prospects. With strong teams, we do valuable work every day. At our production sites in Sempach, Escholzmatt and Crissier, we manufacture solutions that are indispensable in the healthcare sector. This makes us proud. /p pAre you a seasoned pharmaceutical quality professional with a strong understanding of Swissmedic regulations and GDP/GMP standards? B. Braun Medical AG is seeking a Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) to ensure compliance with Swiss pharmaceutical legislation and uphold the highest standards of product safety and quality. As the RP, you will hold legal accountability for the release of medicinal products, be involved in pharmacovigilance, and regulatory compliance. You will act independently in all decisions related to product quality and safety and serve as the primary contact for Swissmedic and other regulatory authorities. As person responsible of pharmaceutical advertisement you ensure compliance of the advertising material with the corresponding local regulatory requirements and decide independently about release / non-release. /p h3Your Tasks Responsibilities /h3 ul liIndependently release or reject imported medicinal products (Swiss market release) and market returns. /li liEnsure compliance with GDP, GMP, and Swissmedic requirements /li liOversee change controls deviations etc. related to medicinal products /li liAdvise internal teams on pharmaceutical compliance and safety topics /li liAct as Responsible Person for advertising for Swiss market release (release of pharmaceutical advertising material) /li liAct as subject matter expert in Audits / Inspections for the areas of expertise /li liEnsure readiness for inspections (ISO / GxP) /li liBe involved in pharmacovigilance systems, including case management and safety communications /li liServe as IMS Process Owner and Coordinator for assigned processes (market release and advertising processes) /li /ul h3Your Profile /h3 ul liUniversity degree in Pharmacy, Life Sciences or a related field /li liRecognized qualification and experience as a Responsible Person (acc. to Swissmedic Guideline I-SMI.TI.17d) and responsible person for advertising (acc. to AWV Art. 25) /li liIn-depth knowledge of Swiss pharmaceutical legislation (HMG, AMBV, AWV) and GDP/GMP standards /li liStrong decision-making and communication skills /li liFluent in German and English (French is a plus) /li liTrustworthy, independent, accountable and committed to continuous improvement /li /ul h3Our Offer /h3 pThis is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! /p h3Benefits /h3 ul liFlexible working hours with the option to work from home /li liGood accessibility by public transport, free parking facilities /li liOur restaurant offers attractive menus at fair prices every day /li liFamily support in the form of extended paternity leave and financial contributions /li liHealth workshops and contributions to sports and/or health-promoting activities /li liSupport for further training: Financial contributions, language courses and a modern learning platform /li liInsurance (NBU) is covered by the employer /li liSports activities over lunch/after work organized by colleagues /li /ul /p #J-18808-Ljbffr