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Regulatory Affair - JD
Regulatory Affair - JD
Regulatory Affair - JD
A quality control reviewer analyses pharma regulatory documents relating to entire lifecycle of
clinical trials intended for development of product or molecule such as Protocol, Investigator
Brochure, Clinical Study Report, Common Technical Document Modules, Investigational
Medicinal Product Dossier, Development Safety Update Report, Informed Consent Form etc.
PRINCIPAL ACCOUNTABILITIES:
Protocol and protocol amendments (all phases), ICFs, IBs, IMPD, CTD modules, CSRs (all 4
phases), benefit and risk assessment (BRA), Narratives, safety reports, Briefing package/book,
registry protocol and reports, manuscripts, and global investigation plan (GIP).
Ensure the rigorous standards of scientific process by taking part in peer-review system
Uphold the integrity of document and thereby helping to maintain quality of data
Help prevent ethical breaches and thereby maintaining the credibility of submissions
GENERAL REQUIREMENTS:
QUALIFICATIONS:
Bachelor / Master’s degree in Pharmaceutical Sciences, (M.Pharm. Pharm D., Ph.D.) or Life
Science degree
SKILLS: