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Freelance Regulatory Affairs CMC

  • Salary: Negotiable per hour
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Pharmaceutical
  • Contact: Eric Bolender
  • Contact Email:
  • Duration: 12 Monate +
  • Start Date: ASAP
  • Expiry Date: 22 July 2021
  • Job Ref: QF_2021_4_1624368489


* Preparation of M2.3 (Quality Overall Summary) and M3 CTD documents for late stage development biologics, supporting EU MAAs and IMPDs filings
* Provides regulatory counsel in document authoring, review and document management system
* Review CMC documents, develop regulatory strategies, and provide risk assessments
* Interpret, develop strategy and lead response preparation on Health Authorities information requests
* Collaborate closely on project-related tpoics with global RACMC and technical experts, across all regions
* Keep current with review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders