Hardworking professional having experience as a Sr. Regulatory Affairs Specialist and Formulation Scientist with record of success in formulation development, process development, experienced in Quality Assurance, change controls, Deviations, regulatory submissions and Post Market Surveillance activities and process optimization developing and implementing regulatory strategies for compliance with FDA regulations and CMC requirements. Expertise: Hands-on expertise in 510(k) documentation and submissions to the FDA and other regulatory authorities. Strong background in regulatory strategy, dossier/submission writing, regulatory gap assessment, risk mitigation, and documentation. Strong understanding of FDA 21CFR (part 11, 820) requirements, QSR, MDD, EU MDR, IND – NDA, ISO 13485, ISO 14971, and other Regulatory Compliance (ICH Guidelines, CFR, ISPE, ISO, Health Canada, PMDA), CAPA, Investigation and Root Cause Analysis, , and documentation for submission to Notified bodies.
Responsible for coordinating, publishing and dispatch of major and complex lifecycle management eCTD submissions such as INDs, ANDA, NDAs
Prepared documentation in support of regulatory filings and submission in the U.S and EU
Conducted regulatory impact assessment for changes to the design, labeling, process, and engineering specifics for medical devices and assist in the development of 510(k) submissions
Led the regulatory team in the participation on audit and field action teams and support post-market activities such as CAPA, issue assessment
Developed and executed aggressive weighted with realistic regulatory strategies for a range of complex regulatory affairs programs with emphasis on requirements and submissions
Prepared of high quality pre and post market submissions for global markets and works with Regional Operating Units to obtain and maintain global product regulatory documentation, approvals, and product renewals
Prepared, reviewed and approved regulatory submissions such as ANDAs, amendments, supplements to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance
Ensured regulatory compliance with Clinical protocols and regulatory policies, Good Clinical Practices (GCP), procedures and guidelines
Reviewed high quality, compliant CMC regulatory documents (Core Dossiers, INDs, CTAs, MAAs, BLA, Variations and other relevant regulatory CMC filings) and support Client in responding to health authority questions within defined timelines
Reviewed and approved relevant DHF documentation, risk analysis, test protocols and reports, clinical evaluation reports and post market surveillance plans
Executed quality control reviews and tracking internally used labeling documents, Core Data Sheet, Core Patient Information Develop and implement regulatory strategies and processes to ensure timely global commercialization of products/changes in compliance with applicable regulations and standards
Performed regulatory Compliance Audits, FDA Form 483, Warning Letters, Consent Decrees, CAPA, 21 CFR and Labeling compliance, Informed Consent, Protocol preparation and review
Generated Standard Operating Procedures (SOP’s) as needed for the Regulatory Affairs group
Performed assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
02/2020 to 05/2021
Regulatory SpecialistApex Systems – Greenwood Village, CO,
Responsibilities included design verification and identifying gaps requiring validation for manufacturing of product transfer
Reported trends in Deviation and CAPA records to monitor performance for continuous improvement
Ensured compliance of Technical Files contents with relevant health authority’s requirements
Prepared design dossiers, technical files, shipment certificates, and product release support documents
Reviewed and approved IFUs, labeling, advertising, and promotional material for compliance with applicable US, EU, and international regulations
Supported the international regulatory affairs team with registration documentation requirements & post-market activities for the EU
Prepared and analyzed marketing approval applications, EU Technical Files, Canadian Registrations, and other international market registration dossiers for new product submissions, license renewals, amendments, and other associated activities for government agencies
Gathered knowledge of the regulatory environment and facilitated non-regulatory departments
Ensured the quality of all submissions in compliance with HealthCanada, ICH, and corporate guidelines
Ensured all technical remediation efforts for over 30 technical files and design dossiers are compliant with current ISO standards and regulations
Prepared, reviewed, and submitted technical documents/ dossiers related to the regulatory affair
Compiled and review quality agreements and vendor qualification for vendors
Assisted with updating Technical Files, Design Dossiers, labels, and packaging (UDI) for Medical Device Products
Reviewed technical documents for submissions and ensure compliance with ICH and FDA regulations
Evaluated changes to regulatory documents via the change control process and formulates strategies to maintain submission goals
Prepared regulatory submissions ANDA documents in accordance with FDA and CMC requirements
Responded to FDA inquiries and questions related to Pharmaceutical Development section (3.2.P.2) and DMFs
Maintained and managed complaint records, and other complaint handling documents
Coordinated and maintained the Corrective Action Preventive Action (CAPA) Process and tracked verification of effectiveness
Reviewed revised product labeling information, package inserts, and container/packaging
Knowledge of IND reports, 21 CFR part 11, GMP and GCP standards
Interfaced with Research and development, Quality Assurance, Compliance, Manufacturing and Analytical departments to obtain the documentation for submissions
Planned, implemented and managed product formulation strategies
Formulated and developed manufacturing process for solid dosage forms wet/dry granulation, granulation, vacuum drying, conventional drying, milling, blending, compression, encapsulation, coating
Record experimental data, analyze results, and maintain accurate and up-to-date notebooks
Developed solid dosage forms from pilot to pivotal scale utilizing design of experiments (DOE) and quality by design (QbD) approaches
Support ANDA/NDA projects from development to approval
Write technical documents such as specifications, test methods, Batch manufacturing records, pharmaceutical development reports, new product batch evaluation protocols and reports
Periodically review SOPs for compliance with cGMPs and revise SOPs
Carry out duties in compliance with all state and federal regulations and FDA guidelines
Provide training to Associate Scientists and Associate Chemists
06/2016 to 08/2017
Laboratory ScientistClearway Pain Solutions Institute – Dover, DE,
Worked on the project Design, Development and Evaluation of Development of Etodolac ER tablets in the Research and Development department
Formulation development from initial stages of brand characterization, review of patent literature, selection of formulation approach & excipients, up to complete development of generic version with manufacturing capability
Experience with various operations of a pharmaceutical firm, manufacturing of tablets (granulation, blending, punching, and coating), capsules, packaging, quality control and their stability testing operations
Thorough documentation in lab note book as per GMP requirements
Performed and documented preventive maintenance and quality control practices, noting best corrective action to remediate issues.
Collected specimen samples for clinical trials and assessment.
Maintained physical lab equipment, detecting malfunctions and troubleshooting to ensure optimum service.
Maintained compliance with disclosure and confidentiality mandates, both internal and regulatory in nature.
Education and Training
Expected in 04/2021
Master of Science: Epidemiology University of Glasgow - United Kingdom, GPA:
Expected in 09/2016
Bachelor of Science: Pharmacy Gokaraju Rangaraju College of Pharmacy - Hyderabad, IN, GPA:
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