Associate Director - EU Regulatory CMC assessment

Posted 17 December 2021
Job type Limited
DisciplineLife Sciences

Job description

For our costumer a global pharmaceutical leader based in Z├╝rich we are looking for an experienced

Associate Director - EU Regulatory CMC assessment (m/f)

Your tasks

  • Establishes a coherent process and maintains transparent communications between Global CMC and Regional Regulatory teams to enable CMC reg assessments
  • Develops, leads and drives EU CMC regulatory assessments, to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
  • Able to establish a working process for assessing CMC changes in close collaboration with the EU RL across therapeutic areas
  • Works with the RA CMC leads and contributing functions to achieve a high quality change description and supporting documentation
  • Assesses regulatory impact in EU region of proposed CMC changes, including determination of type of procedure and possibility of grouping, and effectively communicates objective assessments of the likelihood of success of these regulatory strategies
  • Records the regulatory impact assessment, the assessment or regulatory procedure submission, approval dates in Quality Change Control System and other systems, as applicable
  • Identifies the required documentation and any content, quality and/or timelines issues for EU CMC submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
  • Leads in close collaboration with CMC manager the preparation of submission packages for relevant CMC variations
  • Provides regional regulatory expertise for assigned development and /or life cycle management projects within the therapeutic area of responsibility

Your qualifications

  • Scientific degree
  • min 8 years experience within the pharmaceutical industry and including direct experience in CMC regulatory affairs in development and post-marketing phases for medicinal products in in the pharmaceutical industry and in the Quality environment
  • Strong expertise in the EU region: CMC lifecycle maintenance, Variation Regulation/Guideline; preferred experience in managing multiple filings
  • Experience in CMC regulatory affairs for biological/biotechnological products as an advantage
  • Fluent in English

Your application
Please apply online. For further information about the position, please contact your Kelly recruiter, Simone Mumbauer, PhD (+41 44 225 41 12).

About Kelly We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.