Interim Regulatory Affairs Consultant - CMC

36809
  • USD $100-120 per hour
  • Boston, MA
  • Contract

Walker Cole International is searching for an Interim Regulatory Consultant CMC to join a growing Oncology/Hematology East Coast Biopharmaceutical in Boston, Massachusetts . Our client has multiple, late-phase, novel oncology molecules as well as an early phase pipeline. As the Interim Regulatory Consultant you will be responsible for supporting the development and execution of CMC regulatory strategy for the business.

 

As the Interim Regulatory Affairs Consultant CMC - You will be responsible for: 

  • Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes
  • Collaborating with external consultants and organisations to oversee the execution of regulatory submissions
  • Manage execution / authoring of CMC documentation (Module 1, 2 and 3)
  • Monitoring the regulatory landscape to adapt to changes that will affect the business' portfolio

 

Required experience for Interim Regulatory Affairs Consultant – CMC:

  • A Bachelor's degree in a scientific field with at least 10 years industry experience
  • At least 6 years Regulatory CMC experience, biologics
  • Experience in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
  • A strong understanding of the drug product lifecycle from R&D through to marketing
  • A working knowledge of FDA regulatory guidelines
  • Understanding of scientific principles and capable of interpreting regulatory requirements

 

 

Regulatory Affairs | RA | Head of Regulatory Affairs| GMP | BioPharma | BLA | Pharmaceutical | Regulatory | Submission | Product Dossiers | USA | Global | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D | Regulatory Affairs Consultant – CMC

Lauren McQuade Director - Global Contract US & International

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