Since 1993, ProductLife Group (PLG) has supported clients throughout the life sciences product lifecycle, combining local expertise with global reach and spanning more than 140 countries. 

PLG is a life sciences consulting firm providing outsourced services in the areas of regulatory affairs, quality and compliance, vigilance and medical information. Our expertise extends to both established product monitoring and innovative therapies and diagnostics. 

We are looking for a CMC Specialist Consultant W/M to join our teams. 

Why join PLG? 

  • International Company 
  • Multi-Projects on various types of activity and products in pharma, cosmetics, biotech and medical 
  • Large-scale projects/with internationally renowned clients 
  • Upgrade skills 
  • A dynamic and motivated team 

Group 10

  • Participate in the development of the CMC regulatory strategy (validation strategy, choice of specifications, stability plan) 
  • Support the implementation of the CMC regulatory roadmap, in direct interaction with customers 
  • Prepare, write and compile CMC regulatory documents (complete Module 3, Quality Overall Summary , IMPD, variation files) for small molecules and/or large molecules (biological products) 
  • Examine and assess the conformity of CMC documents (complete Module 3, Quality Overall Summary , IMPD, Variation Files) based on state of the art, current guidelines, local requirements and customer guidelines by performing gap analysis of regulatory documents 
  • Act as point of contact on behalf of clients for CMC regulatory consultations with regulatory agencies (ANSM, EMA, FDA…) 
  • Participate in preparing responses to agency questions 
  • Advise pharmaceutical development: analysis of validation or stability reports 
  • Ensure regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA file and factory procedures 

Group 13

  • Pharmacist B or diploma university in Life Sciences 
  • Minimum 4 years of experience in writing and reviewing module 2.3 (Quality Overall Summary) and module 3 (CMC) 
  • Knowledge and mastery of CMC regulatory requirements for different markets (France, Europe, US) 
  • Rigor and autonomy 
  • Ability analysis and writing 
  • Good interpersonal communication skills 
  • Fluent English required  

CMC Specialist - 267