About the job
ProductLife Group is looking for CMC Officer to join our team in India
Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
Defines strategies for writing documents,
Defines positioning for variation files,
Evaluates 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.
Advises on pharmaceutical development: analysis of validation or stability reports.
Proposes to the client a strategy for validation, choice of specifications, stability plan.
Analyses and/or writes scientific reports based on raw data provided by the client.
Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between
the MA file and factory procedures.
Carries out continuous regulatory monitoring/regulatory intelligence and communicates this to the teams
Contributes to the support and training of newcomers and colleagues (methodology, feedback,
Education and Experience
Master’s degree in Pharmacy
6+ years of experience in CMC in Pharmaceutical Industry
Knowledge of EU regulations for pharmaceuticals
Job Types: Full-time, Temporary, Contract