Deputy Manger / Manager Regulatory Affairs (Biosimilars)

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 strong knowledge of CDSCO, EMA/EU and ICH requirements, particularly CMC and biological product regulations.