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Regulatory Affairs Manager - Switzerland  

Company managed [?] Still accepting applications

Posted on : 08 March 2017

Project Description


ACCOUNTABILITIES
  • Communication with the authority (Swissmedic) and the head office
  • Marketing Authorization Applications for new products
  • Orphan Drug Applications
  • Development of regulatory strategies for new products and the timely provision of documents for Swiss medic in collaboration with the Senior Regulatory Affairs Manager
  • Continuous maintenance of marketing authorizations for all medicinal products (Life-Cycle Management)
  • Preparation and submission of variations concerning the approved products (Quality-, Labelling changes,…)
  • Safety submissions, e.g. Periodic Safety Update Report (PSUR)
  • Provision of packaging material: revision, translation, proofreading and publication of professional and patient information
  • Continuous updating of the product information to be in line with the current CCDS
  • Ensure high quality professional communication when responding to medical inquiries
  • Set-up standardized answers for FAQ (frequently asked questions) or routine requests in collaboration with medical advisors and medical science liaisons
  • Support in creation and maintenance of promotional materials
  • Review of promotional materials and their monitoring for conformity and compliance with regulatory requirements


COLLABORATION WITH OTHER POSITIONS
  • In-house: - All Departments within the LOC
  • Internal: - Global Regulatory Affairs
  • External:-Swissmedic (Authority)



Qualifications

EDUCATION, EXPERIENCE & SKILLS
  • Pharmacist or life science degree
  • German (must), English (must), French good knowledge
  • MS-Office
  • Adobe Professional
  • Team work
  • Communication
  • Pro-active attitude