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Sonal Kale
Regulatory Affairs Manager
Regulatory Affairs Manager
Regulatory Affairs specialist with 12+ years of experience in CMC authoring, lifecycle management, and global regulatory submissions for biologics, biosimilars, and small-molecule products. Proven expertise in developing regulatory filing strategies, compiling CMC modules (1–3), evaluating change controls, and managing post-approval submissions across regulated markets including US, EU, and MEAR. Strong cross-functional collaborator with experience leading submission planning, Health Authority correspondence, and compliance tracking. Skilled in regulatory systems and eCTD publishing platforms with a consistent track record of delivering timely, high-quality regulatory dossiers and driving process improvements.
FORMERLY AT
Amgen India
LOCATION
Chennai, India
AVAILABILITY
Full-time
Skills
eCTD publishing systems
eCTD publishing tools
Educe Software
LifeSphere RIM
Lorenz Docubridge
MS Office
PharmaREADY
RIM systems
TrackWise QMS
Veeva Vault
Work Experience
Regulatory Affairs Manager
Amgen India
May 2025 – Present
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Acts as CMC Product Lead supporting global lifecycle management activities.
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Defines regulatory filing strategy, performs risk assessment and reportability evaluation.
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Authors and compiles variation/amendment dossiers for global submissions.
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Drives process improvements for change management and regulatory workflows.
TECHNOLOGIES
Veeva Vault, Lorenz DocuBridge, LifeSphere RIM, TrackWise QMS, PharmaREADY, Educe Software, MS Office, eCTD publishing systems
Regulatory Affairs Manager (Japan-based Biopharma Client)
Tata Consultancy Services (TCS)
Apr 2018 – Jan 2023
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Led global submissions (EU, MEAR regions) for biologics and small molecules.
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Managed eCTD and non-eCTD submissions for renewals and post-approval activities.
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Defined submission scope, timelines, and responsibility matrix in collaboration with stakeholders.
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Supported business development, automation initiatives, and regulatory intelligence.
TECHNOLOGIES
Veeva Vault, Lorenz DocuBridge, eCTD publishing tools, RIM systems
