01 Nov
|
MSN Group
|
Hyderabad
01 Nov
MSN Group
Hyderabad
Role & responsibilities Deputy Manager / Manager Regulatory Affairs | Biotech/Biologics |India & EU We are looking for an experienced Regulatory Affairs professional 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.
📌 Deputy Manger (Hyderabad)
🏢 MSN Group
📍 Hyderabad