CMC Consultant

CMC Consultant

Job Title: CMC Consultant
Contract Type: Contract
Location: Berkshire, England
Salary: Negotiable
Reference: CMC01_1499692860
Contact Name: Alastair McCartney
Contact Email:
Job Published: July 10, 2017 14:21

Job Description

Project work will range from administrative (formatting per client guidelines, obtaining information in client systems) to complex (developing regulatory strategies for global rollout of post-approval CMC changes and authoring associated submissions) and is dependent upon the needs of the client.

  • Preparation of Marketing Authorisation Applications, Clinical Trial Authorisation applications and INDs
  • Preparation of requests for Scientific Advice from FDA, EMA and EU National Authorities
  • Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
  • Advice on individual study designs, taking into account product type and therapeutic class, and review and interpretation of study data
  • Clinical trial legal representative services for non-EU companies and US Agent services for non-US companies
  • Participates in product development team meetings to ensure inclusion of CMC requirements across various stages of the drug development/approval process. Provides guidance to client on issues impacting CMC information.
  • Develops regulatory strategies for post-approval CMC changes by utilizing existing regulatory affairs knowledge and client systems/ processes.
  • Continues to develop familiarity with regulations and regulatory guidelines and strategy for various biological.
  • Develops working knowledge of regulatory standards, practices, corporate policies, practices and departmental SOPs/work practices · Provides guidance to other peers concerning biologics rules and regulations.
  • Provides guidance to other peers concerning client systems and processes.

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