Posturi disponible

Regulatory Affairs CMC Specialist

21.1.2020

Main responsabilities:

  • Compile dossiers for presentation to regulatory authorities; take all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive;
  • Respond to queries concerning dossiers; manage the response process by involving all stakeholders both within and outside the company (e.g. suppliers) and following up agreed actions in order to respond as rapidly and completely as possible;
  • Take all necessary measures to ensure the granting and the maintenance of the MA for the assigned products;
  • Contribute to regulatory life-cycle management by actively participate in the change control system and variation process; follow up on commitments made with regulatory authorities; prepare variation packages and prepare and contribute to renewal applications;
  • Support, from a regulatory perspective, the transfer of products to manufacturing facilities;
  • Contribute to stability protocols by determining the types of studies required, designing studies and reviewing protocol drafts. Review stability reports for inclusion in marketing authorization applications;
  • Review Drug Master Files or Certificates of Suitability for Drug Substances;
  • Provide regulatory expertise and support to internal departments on technical and regulatory issues concerning registration or post-approval change documents;
  • Keep abreast of regulatory and other developments in the pharmaceutical industry, including relevant legislation, guidelines and pharmacopoeias;
  • Ensure that the internal regulatory database and trackers are kept up-to-date;

Requirements:

  • Chemist/ Biologist/Biochemist/Pharmacist
  • At least 3 year Regulatory Affairs experience
  • Previous work experience in pharmaceutical industry in a similar role is a must
  • English language: advanced level, both speaking and writing; good understanding of English professional terminology
  • Computer skills: very good knowledge of MS Office tools
  • Attention to details
  • Ambitious, responsible person
  • Enthusiastic, proactive
  • Teamwork spirit
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
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