We are looking for an experienced Regulatory Affairs skilled to support Biosimilars
Regulatory submissions for the Indian and European markets at the MSN R&D; Center.
The incumbent will be responsible for regulatory strategy, CMC documentation, CTD/eCTD dossier preparation/review,
regulatory submissions, authority queries, regulatory intelligence and post-approval lifecycle management.
The role will closely collaborate with R&D;, CMC, Analytical Development, Quality, Clinical, Manufacturing and other cross-functional teams. Candidates should possess relevant experience in biotech Regulatory Affairs with solid knowledge of CDSCO, EMA/EU and ICH requirements, particularly CMC and biological product regulations.