Regulatory CMC Consultant

14-03-2024
Job Type
Contract
Emp Type
Full Time
Functional Expertise
CMC
Salary Type
Hourly

Job Description

Regulatory CMC Consultant

Join an unprecedented team, supporting a range of different projects. In this role, you will be driving a number of projects, including developing the eCTD for BLA filngs of Biologicals.

 

Responsibilities:

  • Represents the department on multi-functional project development teams to support regulatory filings

  • Coordinate and provide technical oversight for the generation of Module 3 submissions

  • Authors/drives sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfil regulatory agency expectations

  • Development of responses to health authority inquiries in support of major applications

  • Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions

  • Advise from a technical / regulatory perspective where gaps may lie and ideally predict potential EMA/FDA questions that could arise

  • Mentoring/leading other team members

Requirements:

  • 10+ years in Technical Regulatory CMC experience
  • Small molecules and Biologicals experience (mAbs and Recombinant proteins desirables)
  • BLA authoring and filing experience is necessary
  • Full-time availability from April 

Consultant