CMC Specialist - 141
004-placeholder Morocco, Tunisia - Onsite and offsite both, Remote work possible - CMC 003-clock Permanent contract
CMC Specialist - 072
ProductLife Group is looking for a CMC Specialistto join our dynamic team from Tunisia.
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
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 - 141
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