LOMESHA PATEL

704-***-**** ad39on@r.postjobfree.com Lilburn, GA

PROFESSIONAL SUMMARY

A highly skilled professional with comprehensive experience in the pharmaceutical and healthcare sectors. Possesses a strong foundation in regulatory strategy development, FDA compliance, and quality control analysis, underpinned by a Master of Science in International Biomedical Regulatory Affairs Sciences. Demonstrated expertise in managing complex medication billing processes, enhancing pharmacy operations, and leading quality assurance initiatives to ensure compliance with stringent FDA standards. Proven ability to streamline pharmacy workflows, improve patient service, and resolve insurance claims efficiently. Adept at fostering team collaboration, leading with a solution-focused approach, and driving continuous improvement in regulatory practices. We are committed to advancing patient care and safety through meticulous oversight of regulatory filings and a deep understanding of pharmacy management and operations.

CORE QUALIFICATIONS

Regulatory Affairs Expertise: Demonstrated proficiency in developing and executing regulatory strategies for generic drug pipelines, ensuring compliance with FDA regulations. Skilled in the compilation, submission, and maintenance of regulatory filings using eCTD software, and adept at managing responses to FDA deficiencies to secure timely market approvals.

Quality Assurance and Compliance: Strong background in quality control analysis, including developing validation protocols, and SOPs, and conducting rigorous reviews of production batch records to ensure FDA compliance. Comprehensive understanding of CGMP, Drug Master File, IND, and NDA processes, with a keen focus on maintaining high standards of laboratory cleanliness and equipment calibration.

Operational Efficiency: Proven track record in improving pharmacy operations through quality control measures, efficient medication inventory management, and enhancing patient service by resolving insurance claim disputes. Demonstrated leadership in fostering team collaboration and delivering exceptional patient care in hospital and retail pharmacy settings.

Strategic Communication and Team Leadership: Exceptional communication skills complemented by the ability to lead and empower teams across regulatory affairs, quality control, and pharmacy operations. Committed to enhancing operational efficiencies, patient safety, and regulatory compliance through effective team management and process improvements.

SKILLS

Regulatory Strategy Development FDA Compliance & Filings eCTD Software Proficiency CGMP Knowledge Quality Control Analysis Validation Protocol Development SOP Creation and Implementation Batch Record Review Technical Documentation Evaluation Pharmacy Operations Efficiency Agile Framework Application Team Leadership & Empowerment Data Analysis & Reporting Electronic Health Records Continuous Process Improvement

PROFESSIONAL EXPERIENCE

Regulatory Affairs Associate Aavis Pharmaceutical Ltd, GA 2021 - 2023

Strategically developed and executed regulatory plans for the company's generic product pipeline, ensuring alignment with FDA regulations and guidelines.

Demonstrated expertise in compiling, developing, publishing, submitting, and maintaining regulatory filings, contributing to the streamlined approval process for market release.

Proficiently prepared and managed electronic submissions using eCTD software for generic drug products, effectively coordinating responses to FDA deficiencies to secure timely market approvals.

Showcased a comprehensive understanding of regulatory requirements to optimize submission quality and efficiency.

Spearheaded implementation of CMC regulatory strategy for assigned projects, meticulously compiling data on CMC changes for both marketed and development-stage products. This includes managing manufacturing, analytical, and formulation modifications to comply with regulatory standards.

Ensured accurate and timely compilation of materials for license renewals, updates, and registrations, maintaining regulatory files and databases in exemplary order.

Played a pivotal role in enhancing regulatory processes by preparing SOPs directly related to FDA regulations, ensuring all team members adhere to the latest compliance standards. Familiarity with CGMP, Drug Master File, IND, and NDA processes underscored a robust regulatory knowledge base, facilitating effective oversight of customer complaint regulatory reviews and maintaining up-to-date awareness of industry regulations and standards.

Certified Pharmacy Technician Gwinnett Medical Hospital 2018 - 2021

Played a pivotal role in executing rigorous quality control measures, ensuring the precise and accurate delivery of medications to patients, thereby significantly enhancing patient safety and care standards at Gwinnett Medical Hospital.

Provided critical assistance to nurses in preparing medications and controlled substances, contributing to the streamlined operation of hospital services and supporting patient treatment plans.

Demonstrated leadership by coaching and empowering a team of technicians and pharmacists, fostering an environment of excellence in customer service and patient care, improving operational efficiency and patient satisfaction.

Led the initiative to organize medication inventory and optimize pharmacy operations, including the accurate processing of orders, filling prescriptions, and preparing labels, which resulted in enhanced workflow efficiency and medication management.

Pharmacy Technician Walmart Pharmacy / Express Food & Pharmacy 2015 - 2018

Delivered exceptional patient service by efficiently creating profiles, filling prescriptions, and organizing medications, coupled with managing high call volumes and resolving insurance claim issues, leading to enhanced patient satisfaction and loyalty.

Played a key role in ensuring pharmacy operations adhered to stringent infection-control policies and protocols, contributing to a safe and clean environment for both patients and staff by enforcing rigorous cleanliness and safety standards within the pharmacy.

Proactively resolved insurance claim disputes and maintained comprehensive end-user documentation, streamlining patient service processes and reducing wait times for prescription processing and insurance verification.

Spearheaded the optimization of drug inventory management by accurately ordering necessary medications and supplies and verifying deliveries, ensuring the pharmacy maintained efficient operations and met patient needs without interruption.

Quality Control Analyst Elysium Pharmaceutical 2010 - 2014

Championed quality assurance at Elysium Pharmaceutical by leveraging exceptional analytical and communication skills to enhance product quality, through the development of validation protocols, creation of SOPs, and meticulous review of production batch records, ensuring compliance with FDA standards.

Orchestrated the coordination and thorough evaluation of critical technical documentation, including Bills of Materials (BOMs), product specifications, and test methods, to uphold stringent FDA regulatory requirements, demonstrating a strong commitment to quality and regulatory compliance.

Maintained the highest standards of laboratory cleanliness, ensuring tanks, canisters, small components, centrifuge tubes, and other lab equipment were impeccably clean, thereby contributing to the integrity of quality control processes and the accuracy of test results.

Led the routine calibration, maintenance, and sample analysis of sophisticated laboratory equipment according to company standards, including polarimeters, digital viscometers, fluorophotometers, and UV spectrophotometers, significantly enhancing the reliability and accuracy of analytical data.

EDUCATION

Master of Science in International Biomedical Regulatory Affairs Sciences 2023

University of Georgia, Athens, GA

Bachelor of Pharmacy, Chemistry 2010

Karnataka College of Pharmacy, Bengaluru, IN

Contact this candidate