Umadevi Karnan

Results-driven Regulatory Affairs professional with over 5 years of experience at Pfizer India Pvt. Ltd., specializing in Clinical Trial Regulatory Submissions (CTR/SE), submission management, and centralized regulatory data management. Demonstrated expertise in end-to-end regulatory submission workflows, regulatory compliance, quality control, document management, and cross-functional collaboration across APAC, EME, EU-AFME, LATAM, US, and Canada markets.

Proficient in industry-standard regulatory tools including PEARL Liquent Insights, GDMS, Eu-CTIS Portal, SCC COMPASS, iArchive, PDM, and Siebel. Proven track record of improving data accuracy, ensuring inspection readiness, and adhering to global standard operating procedures (SOPs) in a GxP-regulated environment.

Associate II – Regulatory Affairs, CTRO Submission Management, SM&P, GRS at Pfizer India Pvt. Ltd. (2022-01 – 2026-03)

• Managed end-to-end Clinical Trial Regulatory Submissions (CTR/SE) ensuring accuracy, compliance, and timely delivery across global markets including US, EU, APAC, and LATAM regions.
• Performed Investigator Brochure (IB) tracking including coordination with CRO and CTRO leads, tracking updates, and ensuring aligned submission timelines for regulatory packages.
• Handled Planning Trial Master File (PTMF) report pulling and review to ensure completeness, data integrity, and full alignment with global regulatory requirements.
• Resolved iArchive document management issues to maintain smooth document retrieval and uninterrupted workflow continuity.
• Created and tracked SCC COMPASS cases, maintaining high-quality case documentation, compliance monitoring, and timely follow-ups with relevant stakeholders.
• Downloaded and tracked regulatory documents from the Eu-CTIS portal into PEARL Liquent Insights and GDMS systems, including thorough document metadata validation.
• Conducted iCTA Peer Quality Control (QC) reviews for regulatory documents to ensure format, accuracy, and quality standards are consistently met across all submissions.
• Performed Request for Information (RFI) reconciliation by reviewing, validating, and updating information across multiple regulatory information management systems.
• Collaborated with cross-functional teams including Regulatory Operations, CMC, Safety, and Quality to support audits, regulatory submissions, and timeliness commitments.
• Maintained robust documentation management practices ensuring inspection readiness and strict adherence to global SOPs in a GxP-regulated environment.

Associate II – Centralized Data Management, GRA, GRO at Pfizer India Pvt. Ltd. (2020-01 – 2022-12)

• Demonstrated proficiency in regulatory operational tools including GDMS, Liquent Insight-PEARL, PDM, and Trackwise to support global regulatory operations efficiently.
• Created and configured Company Applications, Product Licenses, package sets, regulatory events, and submissions within regulatory information management tools.
• Participated in Quality Assurance (QA) testing on an ongoing basis, executing SOPs for regulatory operational tools across APAC-EME, EU-AFME, LATAM, US, and Canada markets.
• Served as Subject Matter Expert (SME) exclusively for APAC and EME regions, providing guidance and cross-regional support as required.
• Executed User Acceptance Testing (UAT) for regulatory operational tools prior to system rollout, identifying and resolving defects to ensure smooth deployment.
• Accountable for monitoring the SCC tool and COMPASS dashboard to maintain regulatory compliance and consistent operational standards.

Bachelor of Science (Hons) in Biomedical Sciences – Sri Ramachandra University (2015-01 – 2019-12)

Higher Secondary Certificate in Science – St. Josephs' Anglo-Indian Girl's Higher Secondary School (2015-01 – 2015-12)