Specialist Regulatory CMC

  • Full time
  • View on Map
  • @GiftAbled posted 1 year ago
  • Posted : November 23, 2022 -Accepting applications
  • View(s) 162

Job Detail

  • Job ID 40529
  • D&I Classifications

  • D&I Classifications PWDs
  • PwDs All
  • Job Specifics

  • Experience 3 Years
  • Gender Any
  • Qualifications GraduatePost Graduate

Job Description

Accountability/Interdependence : Provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jourfixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables
Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations (RSTs/JF)

Impact: Ensure provision of high-quality CMC dossiers that meet company’s and health authorities’ requirements Enable representatives from all major disciplines involved to reach agreement on the CMC dossier and strategy

Complexity: Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced CMC personnel

Education: Degree in a Life Science or a related discipline, preferably MSc

Work Experience: 5-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role Minimum 3 years of Global CMC regulatory experience


Required skills