Regulatory Affairs Manager

vor 1 Woche

Sempach, Schweiz JobCloud PPP Vollzeit
Regulatory Affairs Manager (f/m/d)

The Global Regulatory Affairs department of B. Braun Avitum division is seeking a Regulatory Affairs Manager for the Sempach, Switzerland site. The Sempach plant specializes in developing a variety of products for cleaning, disinfecting instruments, and producing medicinal products for skin and wounds.

Discover more about our Sempach location and the reasons why joining B. Braun is beneficial.



Key Responsibilities
  • Managing global regulatory support for biocides and cosmetics
  • Preparing regulatory documentation (R4BP, PIF) for registrations
  • Handling dossier variations following the Change Control process
  • Responding to Competent Authorities' requests during evaluations and addressing deficiency letters promptly
  • Establishing and maintaining an updated database for tracking local Regulatory dossiers
  • Ensuring effective communication across departments on Regional and Global levels
  • Redirecting Product Quality Complaints and Medical Requests to the appropriate departments
  • Developing relationships with decision-makers and opinion leaders to identify market trends
Professional Qualifications
  • University degree in natural sciences (pharmacy, chemistry, biology)
  • Additional training in regulatory affairs (EU, CH, USA, Asia) is advantageous
  • Experience in biocide and cosmetics registration
  • Proficiency in English and German (other languages are a plus)

Personal Qualities
  • Analytical and structured approach to work
  • Strong organizational and communication skills
  • Effective teamwork and interpersonal abilities
Benefits

B. Braun's commitment is to Sharing Expertise. The company originated from a desire for positive transformation, attracting individuals with innovative ideas who collaborate with trust, transparency, and gratitude. All united by the vision: B. Braun safeguards and enhances global health.

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