Fresher or 1-2 years of relevant experience in the regulatory department.
Roles and Responsibilities
Compilation of Common Technical Document (CTD) Clinical and Nonclinical Overviews Modules - 2.4 & 2.5.
Comprehensive/detailed product-related literature search demonstrating the non-clinical/preclinical (2.4, animal) pharmacology and toxicological documentation.
Comprehensive/detailed product-related literature search demonstrating the safety and efficacy with regards to the clinical (2.5, human) studies.
Efficient at performing intensive product-related literature search from MEDLINE, EMBASE, PubMed, Science Direct, Google scholar, pharmacological standard text & reference books, and summary of product
characteristics (SPC) of brand leader confirmed by respective medical authorities.
Responsible for the compilation of query responses from agency/patrons and adhering to the requirements of the agency/patrons during the complete regulatory lifecycle of the product.
Basic knowledge about CTD, directive guidelines (ICH, 2001/83/EC, BE etc.), country-specific regulatory procedures/product timelines, and marketing authorizations.
