74 days ago on jobs.kellyservices.ch

Regulatory Affairs Product Specialist

Kelly Services (Schweiz) AG

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Regulatory Affairs Product Specialist

 

Kelly Scientific Resources is a competent and experienced partner of the life science industry.
 
For our client a major player of the pharmaceutical industry, based in the Zug area we are looking for a
 
Regulatory Affairs Product Specialist
 
Responsibilities
Regulatory Affairs
 

  • Compile and submit 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
  • Maintain awareness of regulatory and technical requirements
  • Document and communicate all process related issues
  • Review promotional material for compliance with local regulations
  • Notify clinical trials to Swissmedic
  • Supports the FvP with the assessment of PQRs

 
Pharmacovigilance
 

  • Collect, investigates and reports Adverse Events to Global Pharmacovigilance and submits Individual Case Safety Reports according to legal requirements to Swissmedic
  • Communicate by phone and written correspondence with customers, medical professionals, authorities and other institutions
  • Control and complies with the legally required as well as internal deadlines

 
Required qualifications

  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD is an advantage
  • 3-5 years of experience in Regulatory Affairs including contact with Swissmedic
  • Proven experience in Pharmacovigilance
  • Excellent German and English skills and good French skills
  • Good written and verbal communication skills
  • Ability to manage multiple projects and deadlines
  • Proofreading, editing and negotiation skills
  • Ability to multitask and prioritize

 
 
Do you recognize yourself in the described profile? Are you a motivated, confident and re sponsible personality who wants to work in a modern and innovative pharmaceutical company?
Apply today!
 
Ms. Tanja Güntert, PhD, Tel. +41 (0)44 225 41 07, will be happy to answer your questions regarding the position.
 
 
Kelly Services (Schweiz) AG, Kelly Scientific Resources, Löwenstrasse 29, 8001 Zürich, 
Öffnungszeiten von Mo - Fr 8h00 – 12h00 / 13h30 – 18h00