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BRBrenntag Schweizerhall AG

Swiss Regulatory Affairs Specialist(m/w/x)

Basel
Full-timeOn-siteSenior

Supporting EMEA divisions with raw material regulatory compliance and documentation. Swiss Medic and European NCA regulations knowledge required. Good pension plan, health insurance.

Requirements

  • Degree or considerable life sciences experience
  • Knowledge of pharmaceutical industry regulations (APIs, excipients, biopharma, traditional pharma raw materials)
  • Knowledge of Swiss Medic and European NCA regulations for API, excipient, raw material distribution
  • Good collaboration and communication skills
  • Proactive work across all levels and functions
  • Understanding of current raw material regulations (traditional Pharma, Biopharma)
  • Ability to resolve compliance issues
  • Ability to respond to complex regulatory queries
  • Flexibility in adapting to changing regulations
  • Flexibility in adapting to changing industry standards
  • Flexibility in adapting to changing project demands

Tasks

  • Support EMEA divisions on raw material supply topics
  • Address regulatory, legal, compliance, quality, and safety issues
  • Complete technical and regulatory documentation for customers
  • Respond to customer information requests in English
  • Source information from internal teams and suppliers
  • Report and document customer requests using KPIs
  • Collaborate with commercial and value-added services teams
  • Lead regulatory topics for customer projects
  • Collaborate with QHSE and supply chain teams
  • Ensure regulatory compliance with current standards
  • Support implementation of new standards (IPEC GMP/GDP, EXCiPACT, GDP)
  • Collaborate within the Pharma Regulatory team on global projects
  • Create and manage product regulatory information
  • Provide training on regulatory topics to commercial teams
  • Provide training on regulatory topics to supply chain teams
  • Support the commercial success of the Pharma business unit

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent
  • Swiss GermanBusiness Fluent

Benefits

Retirement Plans

  • Good pension plan

Healthcare & Fitness

  • Health insurance
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