- Steer error-free regulatory submissions through meticulous checks, overseeing US, US-PEPFAR and WHO, covering OSD and Sterile formulation. Manage and facilitate amendments and post-approval variations- Ensured 95% compliance rate with zero errors in global markets by overseeing and executing timely submission of 15 regulatory filings- Increased efficiency and compliance by 20% by leading a team of regulatory affairs specialists in executing over 50 post-approval variations.- Improved project success rate by implementing a new regulatory strategy that reduced product approval times and leading cross-functional collaboration between R&D and Operations teams to integrate regulatory strategies into site projects.- Integrate regulatory strategies from development to submission, covering various aspects like FDA-controlled correspondence, CGT, and dose-weight proportionality, due diligence (DD) for clinical, PLAIR, etc.- Evaluate and provided the input for dept. SOP; labels, and patient information leaflets for submission and commercial perspective.- Maintain meticulous archives of all regulatory permissions and other regulatory information.- Demonstrate adept multitasking in a fast-paced environment, prioritizing tasks to meet objectives.- Ensure staff motivation, monitoring, and measurement align with organizational targets.- Foster team retention, nurturing, and training, contributing to progressive value addition within the team.

- Managed Post-Approvals: Ensured zero defects in global regulatory affairs by managing variations and annual reports for US, EU, RoW countries, aligning with business priorities.- Regulatory Assessments: Conducted evaluations of change controls and regulatory assessments using system software for global regulatory markets.- Collaboration with QC & R&D: Partnered with Quality Control and Research & Development to include technical documents in registration dossiers on time.- Technical & Regulatory Support: Provided support to business units, CFT, and external DMF stakeholders.- Product Life Cycle Management: Maintained databases and TrackWise entries to ensure seamless product lifecycle management.

- Demonstrated expertise in managing post-approval regulatory activities and addressing ANDA deficiencies- Orchestrated seamless coordination among internal and external stakeholders, ensuring smooth operations

- Technical Document Review: Expertly reviewed documents and compiled 505(b)(2) NDA / ANDAs (NCE-1, PIV, etc.) / Amendments in eCTD format, covering Topical and Solid Oral formulations.- Post-Approval Supplements: Compiled and reviewed supplements, including site transfers, PAS, CBE-30, and CBE-0, along with annual reports for meticulous documentation.- USFDA Deficiency Addressing: Addressed USFDA deficiencies, including Screening, ECD, IR, DRL, and CRL, in a timely manner, showcasing a proactive regulatory compliance approach.- Regulatory Strategy Formulation: Created regulatory strategy notes based on reference product information for a strategic submission approach. Interacted with the FDA for controlled correspondences on Q1/Q2, IIG, Clinical protocol, etc.- API DMF Review: Reviewed Type II API DMF from an ANDA perspective and coordinated with suppliers for regulatory requirements.- ANDA Database Management: Prepared and maintained a comprehensive database for ANDAs and deficiency responses, ensuring precise record-keeping.- Agency Audit Participation: Engaged in Agency Audits, contributed to CAPA formulation, and performed thorough dossier reviews for regulatory compliance and quality enhancement.- Cross-functional Interaction: Coordinated with internal and external stakeholders for project update, strategy, query response, etc.

- Managed regulatory submissions and addressed deficiencies in multiple regions (US, EU, CA, JP, Africa, etc)- Handled post-approval variations and maintained documentation for the product life-cycle- Evaluated change controls for regulatory compliance post-approval.- Coordinated cross-functional responses to regulatory defi ciency letters.- Maintained RegDB and VarDB databases via SAP for regulatory information accuracy.- Supported senior product managers in road-map planning and execution.- Supported DRA initiatives and contributed to project meetings for organizational goal alignment

- Prepared and compiled ANDA submissions in eCTD format, focusing on solid oral dose forms for the US market.- Reviewed documents from ARD, QA, QC, and R&D to ensure accurate submission packages.- Developed product labels and patient information leaflets for clear communication and regulatory adherence.- Facilitated cross-departmental communication to align product development with R&D and Operation team.