global regulatory affairs cmc senior expert in Aubonne

posted
contact
Erika Stegagnini, Randstad Merck Aubonne
job type
temporary
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job details

posted
location
aubonne, vaud
sector
administration
job type
temporary
reference number
176180-382
contact
erika stegagnini, randstad merck aubonne
phone
021 900 35 28

job description

Mission until 31.12.2021The Expert Global Regulatory Affairs CMC (GRA-CMC) is responsible for and contributes to driving all CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and interface on interdisciplinary teams within Global Regulatory Affairs and other Functions.

Accountability

CMC Regulatory strategy and Health Authority interactions:

• Contribute to the global CMC regulatory strategy for the assigned products in target regions/countries. This encompasses contribution to draft the CMC section of the Regulatory Strategy Document (RSD), risk assessment, strategic support and advice.

Management of CMC Regulatory Activities

• Assist senior colleagues for the global CMC strategy and plan for dossiers related to the assigned projects/products. Examples for these dossier comprise clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions.

• Responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals under supervision for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.

• Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan.

• Support to confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team)

• Responsible to track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide

qualification

  • Academic background in Pharma/Biotech/Chemistry or other scientific fields
  • ability to understand and support the development of regulatory strategies and dossiers
  • Practical experience in one of the following area for biotech or chemical molecules: manufacturing process development, transfers, validation or analytical development and quality management
  • Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
  • Good interpersonal skills and flexible mindset
  • Attention to details
  • Ability to think strategically
  • Ability to work in teams
  • Project management
  • Good organizational and planning skills