Saket Kanakdhar
Regulatory And Medical Safety Specialist
Mumbai
Summary
I bring 7+ years of regulatory and quality compliance experience in medical device and biotechnology domain. Skilled in regulatory compliance, validation documentation, and aggregate data review, safety trend analysis, regulatory safety reporting, audit readiness, and product launch as per FDA, and global quality standards.
Overview
9
9
years of professional experience
Work History
Quality Specialist
Astellas Pharma Inc.
01.2023 - 11.2025
- Resolved 7+ nonconformance deviations in TrackWise by conducting root cause investigations and implementing CAPAs, achieving on-time closure in alignment with FDA, GMP, and internal regulatory requirements, while reducing repeat deviation occurrences.
- Managed 150+ controlled document workflows within Veeva Vault, including routing, review coordination, approvals, and archival activities, ensuring 100% data integrity and compliance with GxP documentation standards.
- Partnered with cross-functional teams across Manufacturing, QC, QA, and Regulatory Affairs to support documentation readiness and data migration activities, contributing to successful internal and external audit preparedness, with zero critical observations.
- Maintained compliance with evolving FDA, ICH, GMP, and global regulatory requirements by proactively monitoring regulatory updates, and aligning documentation and quality practices with current industry standards.
- Performed detailed root cause analyses for nonconformance and quality events using methodologies such as the 5 Whys and Fishbone Analysis, accelerating issue resolution timelines, and minimizing operational and compliance risks.
- Improved departmental efficiency and compliance awareness by leading training sessions and knowledge-sharing initiatives for team members, strengthening adherence to SOPs, documentation practices, and quality system requirements.
- Analyzed quality and operational data trends from multiple systems to identify recurring product quality risks and process gaps, delivering actionable recommendations that supported continuous improvement and enhanced process performance.
- Supported quality system optimization initiatives by identifying workflow bottlenecks and recommending process enhancements, contributing to improved deviation management, and documentation turnaround times.
Quality and Regulatory Specialist
Replimmune Biotechnology Research
01.2025 - 05.2025
- Reviewed and approved 50+ qualification and validation protocols, reports, and technical documents to ensure compliance with FDA, cGMP, ALCOA+, and site-specific regulatory requirements, supporting audit readiness, and validation lifecycle activities.
- Managed and tracked over 100 quality system records within MasterControl, including document approvals, change controls, deviations, CAPAs, and change requests, improving QMS workflow efficiency and ensuring timely record closure.
- Conducted detailed batch record reviews for biologics manufacturing operations, supporting on-time product release while ensuring full compliance with cGMP, GDP, and internal quality standards, with minimal documentation errors.
- Enhanced regulatory compliance by developing and implementing robust policies and procedures.
Quality and Regulatory Specialist
Nivagen Pharmaceuticals
09.2023 - 10.2024
- Led cross-functional quality and regulatory support for multiple new product and packaging launches at Contract Manufacturing Organizations (CMOs/CMs), ensuring alignment with global quality systems, GMP standards, and regulatory expectations, while supporting successful commercial readiness.
- Coordinated proactive communication with device reviewers and regulatory stakeholders regarding post-market surveillance activities, testing requirements, regulatory pathways, and submission follow-ups, improving transparency, and supporting timely regulatory responses.
- Supported internal, client, and regulatory audits by retrieving, reviewing, and organizing 200+ controlled quality documents from Veeva Vault, contributing to inspection readiness, and ensuring documentation accuracy, traceability, and compliance.
- Led end-to-end label development and revision activities for health products by coordinating with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams, ensuring 100% compliant labeling aligned with FDA and global regulatory standards.
- Managed regulatory documentation and quality records associated with product lifecycle changes, ensuring timely approvals, audit readiness, and effective cross-functional communication throughout implementation activities.
Quality Assurance Specialist
Genentech
09.2022 - 03.2023
- Supported quality operations and CAPA execution activities, utilizing EVAL for validation approval workflows, improving process efficiency, documentation traceability, and compliance with GMP requirements.
- Executed, monitored, and tracked 75+ quality events within Veeva Vault QMS, including CAPAs, deviations, change controls, and investigations, ensuring timely closure, and sustained regulatory inspection readiness.
- Reviewed and aligned validation lifecycle deliverables, including IQ, OQ, and PQ protocols and reports, with Validation Master Plan (VMP) requirements to ensure consistency, traceability, and compliance with validation standards.
- Collaborated with QA, Validation, Manufacturing, and Engineering teams to resolve quality events and documentation gaps, reducing overdue records, and improving overall QMS effectiveness.
- Analyzed quality performance data across multiple operational areas to support continuous improvement initiatives, strengthen compliance monitoring, and enhance decision-making through data-driven insights.
Pharmacovigilance specialist
Bayer Pharmaceuticals at TCS
04.2018 - 07.2021
- Led end-to-end pharmacovigilance and aggregate safety activities for globally marketed products using Oracle Argus Safety, achieving 95% on-time compliance with SLA-driven global regulatory submissions and reporting requirements.
- Authored, reviewed, and quality-checked aggregate safety reports, including PSURs/PBRERs and benefit-risk evaluation documents, ensuring compliance with ICH E2C, GVP, FDA, and EMA guidelines, while supporting successful regulatory submissions.
- Conducted literature surveillance and comprehensive safety data reviews for adverse event and signal detection activities across post-marketing products, strengthening pharmacovigilance monitoring, and supporting timely risk identification.
- Performed signal validation, aggregate data trending, and safety trend analysis to support proactive identification, assessment, and characterization of potential product safety risks, and emerging safety concerns.
- Analyzed and processed 15–20 complex ICSRs weekly for seriousness, causality, listedness, expectedness, and MedDRA coding accuracy, maintaining high-quality case processing standards, and regulatory compliance.
- Collaborated with global Safety, Regulatory Affairs, Quality Assurance, and Medical Review teams to support health authority inquiries, safety responses, audit readiness activities, and cross-functional pharmacovigilance operations.
Post-Market Surveillance Specialist.
GlaxoSmithKline Pharmaceuticals Limited.
08.2016 - 01.2018
- Authored and maintained aggregate safety and post-market surveillance documentation, including PMS Reports, PSURs, risk assessments, and Canadian Summary Reports, ensuring compliance with EU MDR, Health Canada, GVP, and global regulatory requirements.
- Performed signal detection and statistical trend analysis on post-market complaint data, identifying emerging safety signals, and reducing potential field safety risks by 20%.
- Conducted ongoing safety surveillance, literature review, complaint trending, and aggregate data analysis to support proactive signal management, and product risk evaluation activities.
- Supported benefit-risk management activities by conducting Health Risk Assessments (HRA), Health Hazard Evaluations (HHE), reviewing PMCF data, and contributing to Clinical Evaluation Reports.
- Supported benefit-risk management activities through Health Risk Assessments (HRA), Health Hazard Evaluations (HHE), PMCF data review, and Clinical Evaluation Report inputs.
- Maintained documentation and tracking of complaints, signals, and risk assessments in alignment with Good Documentation Practices (GDP), and company SOPs.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA01-2023
Bachelor of Science - Pharmaceuticals
Pune University
India 04.2001 -
Skills
GMP Regulatory Compliance, Pharmaceutical Audits, Quality Assurance, Validation Processes, Documentation SkillsCAPA Management, Continuous Improvement, Risk Assessment, Problem Solving, Project Management, Technical WritingPBRER/PSUR, DSUR, PADER, Aggregate Safety Reports, Benefit-Risk Evaluation, Signal Management, Aggregate Data Review, Safety Trend Analysis, Regulatory Safety ReportingTrackWise, Veeva Vault, Master Control, Argus Safety, Microsoft Excel, Power BI, Microsoft Office Suite, and JIRA
Timeline
Quality and Regulatory Specialist
Replimmune Biotechnology Research
01.2025 - 05.2025
Quality and Regulatory Specialist
Nivagen Pharmaceuticals
09.2023 - 10.2024
Quality Specialist
Astellas Pharma Inc.
01.2023 - 11.2025
Quality Assurance Specialist
Genentech
09.2022 - 03.2023
Pharmacovigilance specialist
Bayer Pharmaceuticals at TCS
04.2018 - 07.2021
Post-Market Surveillance Specialist.
GlaxoSmithKline Pharmaceuticals Limited.
08.2016 - 01.2018
Bachelor of Science - Pharmaceuticals
Pune University
04.2001 -
Master of Science - Regulatory Affairs
Northeastern University