Open position:
Documentation Management Specialist – R&D Pharmaceutical

  • Management of the Pharmaceutical R&D Department documentation
  • Planning and preparation of CMC section for new drug product registration and for variation applications
  • Expertise support during product development
  • Management of subcontractor laboratories and consultants for carrying out external studies (e.g. E&L study, method development, forced degradation studies, toxicological evaluation…)
  • Identification of the required documentation for CMC submissions and collaboration with the Technology and Analytical Development Teams to establish the technical data and documents delivery
  • Management and verification of the pharmaceutical department documentation in order to be in compliance with the Authority’s request, the current Guidelines for project management
  • Management of the procedures and documentation related to Design & Development of Medical Devices in accordance to ISO 13485 and MDR requirements.
  • Elaboration of the regulatory strategy in collaboration with the other R&D pharmaceutical functions and with Regulatory Affairs in terms of product development and registration
  • Evaluation and preliminary qualification of API and excipients supplier and manufacturer (including the DMF gap analysis)
  • Review of the post-approval CMC changes and assessment of the impact on the dossiers. Definition of the strategies for the variation package in collaboration with the Head of Pharmaceutical department and RA and preparation of the concerned CMC section
  • Collecting and writing the responses to inquiries from Regulatory Agencies on CMC content of regulatory submissions
  • Preparation of meeting materials and attending to Health Authority advices related to CMC grid development activities and submissions
  • Evaluation and verification of approved dossier for lifecycle drug product management

Your Profile
  • Bachelor’s degree in scientific disciplines, preferably in Pharmacy, Pharmaceutical Chemistry and Technologies or Biology.
  • At least three years of experience in similar role, gained within pharmaceutical companies in the Active Pharmaceutical Ingredients and / or Finished Products environment. Particularly focused on Medical Device experience
  • Knowledge of ICH/EU/US/Swiss guidelines related to technical subjects of development, manufacturing, stability and photostability studies, elemental impurities, E&L, Analytical methods validation
  • Excellent interpersonal and negotiation skills
  • Analytical thinking with problem solving orientation
Work location
IBSA Institut Biochimique SA, Manno, Ticino, Switzerland


Business unit
Pharmaceutical Research ans Development

Ai sensi degli articoli n°1 L.903/77 e n°4 L.125/91 questo annuncio e diretto a candidati dell'uno e dell'altro sesso.

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