CMC Specialist - 072

ProductLife Group is looking for a CMC Specialist to join our dynamic team from Tunisia.

 

About us

Group 10
Responsibilities

You will have the following responsibilities:

  • Preparing CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Reviewing CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Defining strategies for writing documents
  • Defining positioning for variation files
  • Evaluating the conformity of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents
  • Advising on pharmaceutical development: analysis of validation or stability reports
  • Proposing to the client a strategy for validation, choice of specifications, stability plan
  • Ensuring regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA dossier and factory procedures
  • Carrying out training sessions in CMC regulatory affairs
  • Carrying out a continuous regulatory watch/regulatory intelligence and communicate it to the teams
  • Contributing to the support and training of newcomers and colleagues (methodology, feedback, tools)
  • Managing the client relationship, project control and contractual aspects as a project manager

Group 11
Education

At least a Master’s Degree in Health-related studies

 

Group 12
Experience

At least 5 years of experience on CMC activities

Group 13
Profile

We are looking for someone with the following skills:

Hard skills:

  • Knowledge of the module 3 writing and quality variations writing (life cycle management)
  • Knowledge of the European/International guidelines
  • Experience in managing simple and complex projects
  • Capabilities to assess change controls

Soft skills:

  • Customer satisfaction oriented
  • Excellent time management skills
  • Good communication skills
  • Ability to multi-task
  • Team-player
  • A professional level of English is required
  • Good IT knowledge (especially Office 365)

CMC Specialist - 072