29 Aug
|
MSN Group
|
Hyderabad
29 Aug
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 robust knowledge of CDSCO, EMA/EU and ICH requirements, particularly CMC and biological product regulations.
📌 Deputy Manger / Manager Regulatory Affairs (Biosimilars) (Hyderabad)
🏢 MSN Group
📍 Hyderabad