Palli Nomuganesh

• Dossier Review & Approval: Lead the review and approval of critical dossiers, ensuring accuracy and compliance with organizational standards. Oversee the approval process, coordinating with relevant stakeholders to meet project objectives and deadlines.
• Workload Management: Strategically manage and optimize workload capacity across the LATAM, US, and Canada teams. Adapt to changing deadlines and project demands by reallocating resources and adjusting priorities to maintain operational efficiency and team performance.
• Team Support & Development: Provide guidance and support to team members, addressing challenges and facilitating professional development. Foster a collaborative environment to enhance team productivity and morale.
• Performance Monitoring & Reporting: Monitor and analyze team performance metrics, delivering comprehensive reports to clients on a monthly basis. Identify trends and areas for improvement, implementing strategies to enhance service delivery and client satisfaction.
• Client Presentation & Coordination: Prepare and present Global Operational slides for client meetings, ensuring alignment with client expectations and project goals. Coordinate with regional leads to compile and communicate relevant operational updates and insights.
• Cross-Departmental Liaison: Act as a key liaison between departments, facilitating effective communication and collaboration. Resolve project-related issues promptly and efficiently, ensuring seamless execution and alignment with project requirements.
• Resource Management & Compliance: Oversee project resources, ensuring adherence to project requirements and client expectations. Implement and enforce compliance measures to maintain project integrity and quality standards.
• Strategic Leadership: Develop and implement strategic initiatives to improve operational processes and enhance overall team performance. Provide thought leadership and guidance to drive continuous improvement and achieve organizational objectives.

Senior Manager – Navitas (Client: Pfizer)

• Leadership & Team Management: Successfully led a team for over 7 years, consistently receiving client commendations for the timely and high-quality delivery of submissions to health authorities. Demonstrated strong leadership by implementing new working models to enhance global deliverables and manage diverse regulatory projects.
• Project Planning & Execution: Spearheaded the development and execution of project roadmaps and plans, aligning resources and ensuring seamless submission delivery. Managed project timelines, monitored activities, and maintained rigorous adherence to schedules and quality standards.
• Client & Regional Coordination: Acted as the primary liaison with clients and regional regulatory contacts, facilitating effective communication and feedback. Leveraged knowledge from international submissions to drive best practices and foster global knowledge-sharing.
• Operational Oversight: Managed project plans, invoice preparation, and onboarding/offboarding activities for the entire regulatory team. Coordinated with regional leads to prepare Global Operational slides for client meetings, ensuring alignment with client expectations and project goals.
• Quality Assurance & Compliance: Oversaw internal and external audits, ensuring accuracy and up-to-date records. Maintained and updated Statements of Work (SOW) and Master Service Agreements (MSA) to ensure compliance with client requirements.
• Metrics & Reporting: Monitored and analyzed team performance metrics, presenting detailed reports to clients on a monthly basis. Developed strategies for continuous improvement based on performance insights.
• Resource & Workload Management: Managed workload capacity in response to shifting deadlines, providing support and assistance to team members as needed. Ensured effective resource allocation and project execution to meet evolving demands.
• Issue Resolution & Support: Resolved publishing and submission issues, offering guidance to the team on problem resolution and maintaining high-quality output standards. Actively supported the team in achieving optimal performance and addressing any project-related challenges.
• Team Engagement & Well-being: Conducted icebreaking activities to foster a positive team environment and maintain team health. Implemented initiatives to enhance team cohesion and morale.
• Information Security: Served as a member of the Information Security Group (ISG), overseeing information security within the regulatory department and ensuring compliance with relevant protocols and standards.

Manager – Navitas (Client: Pfizer)

• Team Leadership & Mentorship: Managed multiple teams, offering expert advice, mentoring, and guidance on regulatory and submission requirements. Provided strategic direction on submission strategies, dossier content, and eCTD submission formats, leveraging deep knowledge of industry standards.
• Global Submission Plan Execution: Drove the execution of the Global Submission Plan by collaborating effectively with team members and external vendors. Ensured seamless coordination and integration of all components for dossier submissions to health authorities.
• Project Management: Successfully managed new projects by developing comprehensive roadmaps and project plans. Coordinated resource alignment, executed submission delivery plans, and monitored activities to ensure timely and high-quality outcomes.
• Administrative Oversight: Oversaw project plans and invoice preparation for the entire regulatory team using Project Server. Managed onboarding and offboarding processes, internal and external audits, and maintained up-to-date Statements of Work (SOW) and Master Service Agreements (MSA).
• Workload & Metrics Management: Effectively managed workload capacity in response to changing deadlines. Monitored and analyzed team performance metrics, presenting detailed reports to the client on a monthly basis. Balanced workloads within the subteam by running reports on planned submissions and the Book of Work.
• Client & Regional Coordination: Coordinated with regional leads to prepare Global Operational slides for client meetings. Acted as a liaison between departments to facilitate communication, resolve project-related issues, and ensure alignment with client expectations.
• Issue Resolution & Quality Assurance: Addressed and resolved publishing and submission issues. Assisted the team in troubleshooting problems and ensuring adherence to quality standards, resulting in successful and timely submissions.
• People Management: Managed direct report performance and evaluations, providing leadership and guidance to foster team development and achieve performance goals.
• Operational Efficiency: Proactively monitored progress across all dossier components, interacting with responsible parties to ensure timely receipt and quality results. Implemented strategies to optimize resource use and enhance submission processes.

Team leader– Navitas (Client: Pfizer)

• Team Leadership & Recognition: Successfully lead a team of 20 members, consistently delivering regulatory submissions to health authorities on time and with zero quality issues. Honored with the prestigious GEM Award and Pfizer’s top OWNIT Award for exceptional performance and client satisfaction.
• Client & Submission Support: Act as an individual contributor supporting regulatory submissions for European countries, Australia, New Zealand, and Switzerland. Coordinate and facilitate key submission and issue-driven meetings, representing senior management and driving submission publishing timelines.
• Meeting Facilitation & Coordination: Independently lead sub-team meetings for major submission planning, and coordinate kick-off meetings for new submissions. Develop and update job aid documents for departmental processes to ensure consistency and efficiency.
• Process & Compliance Management: Oversee research for legal due diligence activities, including document and dossier management related to acquisitions, partnerships, and divestitures. Manage internal audits and regulatory agency inspections, ensuring compliance and accuracy.
• Workload & Performance Management: Run reports on the Book of Work and planned submissions to ensure balanced workloads within the subteam. Conduct direct report performance evaluations, providing feedback and support to enhance team development and effectiveness.
• Regulatory Expertise: Possess extensive knowledge of global regulatory practices, electronic submission guidelines, and requirements. Proficient in using electronic document databases, publishing systems, and computer systems, including Microsoft Office, Outlook, eCTD viewers, and web-based applications.
• Technical Savvy & Adaptability: Demonstrate technical proficiency and adaptability in a dynamic environment, leveraging a deep understanding of electronic submission processes and systems to drive successful project outcomes.

Associate Submission Manager – Navitas (Client: Pfizer)

• Hub Submission Management: Coordinate, prepare, review, and submit regulatory dossiers for European countries, Australia, and New Zealand. Manage submission procedures across National, Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), and Centralized Procedure (CP) frameworks.
• Meeting Participation & Coordination: Attend and participate in Submission Team and kick-off meetings, representing the Submission Manager (SM). Actively contribute to discussions and drive timelines for submission publishing.
• Regulatory Process Handling: Oversee the submission process, ensuring all documentation meets regulatory standards and submission timelines are adhered to. Collaborate with team members to ensure accurate and timely dossier preparation and submission.
• Documentation & Review: Conduct thorough reviews of submission dossiers to ensure completeness and compliance with health authority requirements. Assist in preparing and organizing necessary documentation for successful submissions.
• Submission Procedures Management: Handle various submission procedures, ensuring adherence to regulatory guidelines and processes specific to National, MRP, DCP, and CP submissions.
• Team Coordination: Work closely with team members to support submission activities, address any issues that arise, and facilitate effective communication throughout the submission process.

• Coordination with technical teams, Authoring and review of CMC modules as per templates
• Preparation of registration dossier, Annual reports, Amendments and Supplements for US region
• Ensure the availability of data required for filing of the post approval changes and annual reporting of drug products
• Have experience with preparation and review of labeling documents
• Review and approval of specifications, Analytical procedures, MVSR, MTSR, BMR, BPR, Stability protocols and handling of Regulatory queries as per regulatory requirements
• Have an experience in the field of Analytical R&D and well knowledge about Analytical tests like Dissolution, Assay, UOD, CU, Related substance, Method Equivalency and Validation
• Arranging and attending meeting with cross functional teams and providing regulatory inputs during different stages of product development
• Actively involved in plant Audits Have good understanding and interpretation of ICH guidelines, USFDA and other Regulatory guidance's.