Experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations.
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
Performs testing not only of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records. Carry out checks of record documentation.