Maya Singh
Deputy manager
Medical
Cipla
India
Biography
Regulatory Affairs specialist with over 7 years of experience in pharmaceutical industry and have strong understanding of CMC, regulatory strategy and project management. Compilation and reviewing of regulatory dossiers in CTD / eCTD/ ACTD / Country specific format in submission for EU/ Brazil / MENA / ASEAN Countries/South Africa,South Korea and Hong Kong. Co-ordination with country regulatory counterparts for regulatory compliance during and after approval. Communicating with Global Marketing persons for dossier registration and to resolve the issue piled up during the process of registration and re-registration.
Research Interest
CMC, regulatory strategy and project management