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Vidhya Silvanose

@vidhyasilvanose

Message

Regulatory Affairs CMC professional specializing in ANDA submissions, FDA correspondence, and post-approval compliance.

United States

Message

What I'm looking for

I’m looking for a role in Regulatory Affairs CMC where I can own ANDA lifecycle submissions, drive FDA correspondence, and strengthen compliance through risk assessment and cross-functional execution.

I’m a Regulatory Affairs CMC professional with 10+ years of pharmaceutical industry experience supporting ANDA submissions, FDA correspondence, and post-approval lifecycle management. I bring proven expertise in eCTD submissions, Module 3 CMC documentation, and regulatory compliance within cGMP environments.

I prepare Annual Reports by coordinating Field Alert Report (FAR) information and incorporating Annual Product Review (APR) data to ensure complete, compliant submissions. I lead and support responses to FDA Complete Response Letters (CRLs) and Deficiency Response Letters (DRLs), using risk assessment and change control to anticipate FDA review questions and strengthen submission readiness.

I’m known for FDA inspection readiness and cross-functional collaboration with QA, Manufacturing, and R&D. I maintain regulatory lifecycle updates in systems like Veeva Vault and TrackWise, and I’m also familiar with evolving 505(b)(2) regulatory strategies, including awareness of IND applications and protocol amendments, grounded by my microbiology background.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs CMC Analyst

Current

American Regent

May 2022 - Present (4 years)

Prepared and supported original ANDA submissions in eCTD format, including Module 3 CMC documentation. Led responses to FDA CRLs/DRLs and prepared Annual Reports by integrating APR and FAR information while performing regulatory risk assessments and maintaining lifecycle documentation in Veeva Vault and TrackWise.

ANDA ECTD Publishing Module 3 CMC Documentation Field Alert Report (FAR) Integration Risk Assessment Veeva Vault Trackwise 505(B)(2) Awareness

Scientist II – Microbiology

Hikma Pharmaceuticals

Oct 2014 - May 2022 (7 years 7 months)

Performed microbiological testing under cGMP for raw materials, in-process, and finished products. Supported regulatory compliance through deviation investigations, environmental monitoring, method validation, antimicrobial effectiveness testing, and audit/inspection readiness while maintaining data integrity in Veeva and LabWare.

Environmental Monitoring Antimicrobial Effectiveness Testing Data Integrity Veeva Vault & Regulatory

Scientist – Microbiology

Cook Medical

Dec 2012 - Sep 2014 (1 year 9 months)

Conducted sterility testing, bioburden analysis, and environmental monitoring in support of validated laboratory operations. Supported microbial identification and validation studies and prepared laboratory documentation aligned with regulatory and quality requirements.

Environmental Monitoring Microbial Identification Testing Lab Documents Antimicrobial Or Microbial Assay Support Compliance Ready Records

Research Associate (Molecular Biology)

Indiana University

Feb 2007 - Dec 2012 (5 years 10 months)

Conducted molecular biology research including PCR, sequencing, and microbial analysis. Developed and performed quantitative PCR assays and supported genetic analysis with appropriate laboratory documentation.

PCR Molecular Genetic Analysis Lab Documents Data Analysis

Adjunct Faculty – Biology/Microbiology

Ivy Tech Community College

Taught undergraduate Biology and Microbiology courses and developed laboratory curriculum and instructional materials. Supported student learning through course instruction aligned with lab-based learning objectives.

Biology Instruction Curriculum Development