52 days ago on shire.com

Regulatory Affairs Specialist (Location Zug)

Shire International GmbH

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Regulatory Affairs Specialist (Location Zug)

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Posting TitleRegulatory Affairs Specialist (location Zug)Job Id50086QSearch Location(s)Switzerland, Zurich, VolketswilJob CategoryRegulatory Affairs


Regulatory Affairs

  • Compile and submit, in a timely matter, regulatory documents according to regulatory requirements
  • Provides assistance in creation  of supporting documentation for regulatory submissions
  • Prepare, review, and approve labeling and SOP's
  • Respond to regulatory authorities questions with strict deadlines
  • Maintain regulatory files in a format consistent with requirements
  • Obtain, maintain and update existing regulatory authorizations
  • Manage all regulatory activities
  • Maintain awareness of regulatory and technical requirements
  • Document and communicate, in a timely matter all process related issues
  • Review promotional material for compliance with local regulations
  • Develop regulatory project plans
  • Participate as an active team member and provide regulatory advice to project teams as required
  • Represent or lead Regulatory Affairs in small project teams
  • Support Business for obtaining reimbursement
  • Notify clinical trials to Swissmedic
  • Supports the FvP with the assessment of PQRs


  • Collects, investigates and reports Adverse Events to Global Pharmacovigilance and submits Individual Case Safety Reports according to legal requirements to Swissmedic
  • Communicates by phone and written correspondence with customers, medical professionals, authorities and other institutions

  • Controls and complies with the legally required as well as internal deadlines

  • Maintain awareness of local regulations and ensure compliance based on national regulation



  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD is an advantage


  • Number of years of experience: 5 years
  • Field of expertise: Regulatory Affairs or equivalent experience within a pharmaceutical company, CRO, or similar organization

Functional/specific competencies

  • Scientific knowledge 
  • Written and verbal communication skills
  • Knowledge of regulations
  • Negotiation skills
  • Proofreading and editing skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  •  Ability to identify compliance risks and escalate when necessary
  • Comply with regulations and standards and protect Baxalta’s public reputation

Language skills

  • German Excellent
  • English Excellent
  • French Good 
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