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.
GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials.
You will be responsible for preparation, review and submission of Dossier in ANZ and Emerging Markets as per the applicable regulatory guidance in Emerging Markets.