CMC Specialist - 141

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

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

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

At least 5 years of experience on CMC activities