Responsible person (according to TPA/MLPO) & Responsible Person for Advertising

Stellenbeschreibung

Sie sind ein wichtiger Teil unserer Zukunft. Hoffentlich sind wir auch ein Teil Ihrer Zukunft! Bei B. Braun schützen und verbessern wir die Gesundheit der Menschen weltweit. Sie unterstützen diese Vision, indem Sie Ihr Know-how einbringen und Innovation, Effizienz und Nachhaltigkeit als Werte teilen. Deshalb möchten wir unser Unternehmen gemeinsam mit Ihnen weiter entwickeln. Mit Blick auf Ihre Zukunft leisten wir gemeinsam einen Beitrag zur Gesundheitsversorgung weltweit, mit Vertrauen, Transparenz und Wertschätzung. Das ist Sharing Expertise.

Unternehmen: B. Braun Medical AG

Stellenstandort: Sempach, Luzern, Switzerland

Funktionsbereich: Klinischer/medizinischer Bereich

Arbeitsmodell: Hybrid

Anforderungsnummer: 6606

As 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.

Are 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.

Your Tasks & Responsibilities

• Independently release or reject imported medicinal products (Swiss market release) and market returns. Ensure compliance with GDP, GMP, and Swissmedic requirements
• Oversee change controls & deviations etc. related to medicinal products - Advise internal teams on pharmaceutical compliance and safety topics
• Act as Responsible Person for advertising for Swiss market release (release of pharmaceutical advertising material)
• Act as subject matter expert in Audits / Inspections for the areas of expertise
• Ensure readiness for inspections (ISO / GxP)
• Be involved in pharmacovigilance systems, including case management and safety communications
• Serve as IMS Process Owner and Coordinator for assigned processes (market release and advertising processes)

Your Profile

• University degree in Pharmacy, Life Sciences or a related field
• Recognized 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)
• In-depth knowledge of Swiss pharmaceutical legislation (HMG, AMBV, AWV) and GDP/GMP standards
• Strong decision-making and communication skills
• Fluent in German and English (French is a plus)
• Trustworthy, independent, accountable and committed to continuous improvement

Our offer

This 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!

Benefits

• Flexible working hours with the option to work from home
• Good accessibility by public transport, free parking facilities
• Our restaurant offers attractive menus at fair prices every day
• Family support in the form of extended paternity leave and financial contributions
• Health workshops and contributions to sports and/or health-promoting activities
• Support for further training: Financial contributions, language courses and a modern learning platform
• NBU is covered by the employer
• Sports activities over lunch/after work organized by colleagues