The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Manager
located at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and surface disinfection as well as medicinal products for use on skin and in wounds.
Find out more about
our Sempach site. and why it is
worth working for B. Braun.Tasks & Responsibilities- Worldwide marketing authorisation and regulatory support for biocides and cosmetics
- Creation of regulatory
documentation (R4BP, PIF) for acquiring and maintaining registrations - Handle variations to the dossier in accordance with the Change Control process
- Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific timeframe
- Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region
- Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production area, Medical Affairs, Marketing)
- Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/Medical Affairs
- Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market
Professional skills- University education in the natural sciences (pharmacy, chemistry, biology)
- Further training in the area of regulatory affairs (EU, CH, USA, Asia) would be an advantage
- Experience in the registration of biocides and cosmetics
- Very good written and spoken English and German skills (any additional skills are beneficial)
Personal skills- Analytical and structured way of thinking and working
- High organizational and communication skills
- Good teamwork and interpersonal skills
What we offer Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attract people who express progressive ideas and implement them together with trust, transparency and appreciation. Because all follow the same vision: At B. Braun, we protect and improve the health of people worldwide.