Looking for a job

Nayana Makwana

@nayanamakwana

Message

I publish and validate compliant eCTD regulatory submissions for US and Canada markets.

India

Message

What I'm looking for

I'm looking to continue publishing and validating electronic regulatory submissions in a fast-paced, compliance-focused environment, collaborating across teams to deliver high-quality, audit-ready work.

At Tata Consultancy Services, I assemble, publish, and validate electronic regulatory submissions for US and Canada markets, ensuring compliance with ICH guidelines and agency-specific requirements.

I use eCTD Express, Veeva Quality Vault, Veeva Vault RIMS, and Lorenz Validator to uphold regulatory integrity and resolve submission queries with cross-functional teams.

Previously at IQVIA Holdings, Inc., I configured and maintained project databases, supported protocol amendments, conducted validation checks, and kept documentation audit-ready.

Experience

Work history, roles, and key accomplishments

Current

Senior Publisher

Current

Tata Consultancy Services

Apr 2019 - Present (7 years 5 months)

Assembled, published, and validated electronic regulatory submissions to meet compliance standards. Ensured adherence to ICH guidelines and agency-specific requirements.

ECTD Express Veeva Vault QualityDocs Lorenz Validator Regulatory Submissions ICH Guidelines Validation

Lab Set up Specialist

IQVIA Holdings, Inc.

Oct 2017 - Mar 2019 (1 year 5 months)

Configured and maintained project databases to ensure data integrity and quality standards. Supported protocol implementation and amendments, aligning documentation with procedures and customer requirements.

Database Management Data Integrity Validation Documentation Cross Functional Collaboration