Seetharam

Supported FDA/EMA audits by streamlining documentation across departments, reducing audit prep time by 30%.

Utilized Agile methodologies to enhance project workflows and reduce cycle time by 20%.

Implemented protocol amendments, minimizing operational delays by 10%.

Managed full lifecycle of 10+ clinical trials, improving data collection accuracy by 25% and ensuring compliance with timelines.

Led safety submission projects, achieving a 100% regulatory acceptance rate.

Managed a team of 18 professionals to ensure timely, high-quality regulatory submissions.

Improved regulatory systems and introduced quality check protocols, reducing submission time by 10% and increasing accuracy by 25%.

Acted as liaison with regulatory bodies, aligning timelines and strategies across stakeholders.

Handled safety-related queries and standardized regulatory submission templates, reducing client complaints by 12%.

Ensured compliance with global standards (ICH E2E), achieving a 100% audit pass rate.

Streamlined safety data integration into submissions, reducing processing errors by 15%.

Maintained 100% accuracy in case report documentation using digital tools that improved tracking efficiency.

Developed project roadmaps with timelines and budgets, improving delivery efficiency by 20%.

Monitored milestones and risk indicators, achieving 95% on-time project delivery.

Coordinated with R&D, QA, and QC teams to ensure smooth project execution and reduced workflow bottlenecks by 15%.

Implemented cost optimization strategies and negotiated with suppliers, cutting material costs by 8%.

Maintained accurate documentation and reporting for over 10 active projects using MS Project, improving reporting accuracy by 30%.