Overview
Responsible person (according to TPA/MLPO) & Responsible Person for Advertising
You’re an important part of our future. At B. Braun, we protect and improve the health of people worldwide. We would like to develop our company with you, contributing to health care worldwide with trust, transparency and appreciation.
Company: B. Braun Medical AG
Job Posting Location: Sempach, Luzern, Switzerland
Functional Area: Clinical/medical area
Working Model: Hybrid
Requisition ID: 6606
As a Swiss subsidiary of the B. Braun Group, we are a market leader in Switzerland with over 1,100 employees. We manufacture solutions at our sites in Sempach, Escholzmatt and Crissier that are indispensable in the healthcare sector.
Role objective: Ensure compliance with Swiss pharmaceutical legislation and uphold the highest standards of product safety and quality. As the Responsible Person (RP), you will hold legal accountability for the release of medicinal products, be involved in pharmacovigilance and regulatory compliance, and act as the primary contact for Swissmedic and other regulatory authorities. You will also act as the person responsible for advertising and ensure compliance of advertising material with local regulatory requirements.
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 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 (Swissmedic Guideline I-SMI.TI.17d) and responsible person for advertising (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 dynamic organization where decisions are taken quickly and you can actively participate in shaping our future.
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.
Contact: B. Braun Medical AG | Andrea Grob | +41 58 258 5611
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