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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE, PHONE NUMBER AVAILABLEEDUCATION:MS in Project Management, GPA: 4.Street Address /4.00 August 2021 Harrisburg University of Science and Technology, Harrisburg, PA. MS in Cell and Molecular Biology, GPA: 3.66/4.00 August 2016 University of Texas at Dallas (UTD), Richardson, TX B.Tech in Bioengineering, 8.19/10.00 May 2013SASTRA University, Thanjavur, IndiaAwards: Subject topper in Immunology, Neurobiology and Biomaterials SKILLS: Regulatory filings, Amendments, Post approval variations, Annual reports, RTQs, Commitments, Change Controls Authoring of M3 (Quality/CMC) documents for global regulatory filings in major markets like US, EU, AU, NZ, CA, CH, and most/rest of the world markets; M1 & M2 CTD documents Risk Analysis and Management, Gap Analysis, Impact Assessment, Deviation Management, CAPA, OOS Process development, Process Verification, Process Validation, Continuous Process Verification Critical Process Parameters, Critical Quality Attributes, Critical Material Attributes Good understanding of eCTD structure, and FDA, EMA, ICH, USP, & NF standards for Biotech Products/Biologics Knowledge of FDAs, EMAs CMC regulatory submission requirements Current Good Manufacturing Practices, Good Documentation Practices, and Good Laboratory Practices Technical writing, Designing, preparing, editing and review of documents; Ability to work with overseas Contract Manufacturing Organizations (CMOs), Contract Service Providers Microsoft Office (Outlook, Word, Excel, PowerPoint, Visio, Project), Veeva Vault QualityDocs & RIM, REDS (EDMS), GCM Trackwise, SharePoint, Box Excellent Attention to Detail, Problem solving, Analytical thinking; Organizational, planning, oral and written communication skills Biologics like Monoclonal antibodies, Immunotherapy/Gene therapy & Oncology related products; Molecular Biology and Cell biology Laboratory TechniquesWORK EXPERIENCE:Senior Regulatory Affairs Consultant II, (SynerG Biopharma group, Client: Merck & Co.) May 2022-Present Authoring, execution, review and submission of multiple global CMC post approval variation submissions & associated documentation for a blockbuster biologics product impacting over 75 markets (including major markets like US, EU, CA, AU, NZ, CH, IL and MOW markets in the APAC, LATAM and EMEA regions). Responsible for the development, establishment and maintenance of regulatory strategy documents and submission trackers for managing concurrent post approval variation submissions (over 15 changes) impacting key CMC sections of a blockbuster biologics product across ~75 markets. Manage and support M1, M2 and M3 CTD documentation streamlining efforts across global markets; tracking of release, submission & approval timelines for various post approval changes; monitoring of country specific deliverables and adherence to regulatory strategies, filing categories and bundling requirements. Coordinate with various CMC global cross-functional teams, strategists and external contract organizations, as needed, to support the execution of country specific regulatory strategies, requirements and ensure consistency and acceptability of information. Support the preparation and development of timely response to query (RTQ) documents for Health Agency Information requests pertaining to a blockbuster biologics product. Perform review and redactions of regulatory submission and associated documentation to help the implementation of a new formulation of a blockbuster biologics product at a contract manufacturing site. Led a major project for the optimization of global regulatory submission documentation lifecycle management as part of the post approval submission acceleration efforts. Responsible for the review and consolidation of various upstream and downstream batch manufacturing process records of a blockbuster biologics product, as part of the post approval submission acceleration efforts.Regulatory Affairs Specialist, (RevereIT, Client: Advaxis Inc.), NJ Mar 2019-May 2022 Authoring and maintaining Module 3 sections of Investigational New Drug (IND) & MAA (Marketing Authorization Approval) applications, Annual reports, DSURs & amendments for pipeline products. Author Module 2 Quality overall summary, review of Module 3 CMC information and all submission documents to ensure consistency with related filings and regulatory requirements documentation for submissions to FDA. Interact with manufacturing and quality groups and contract organizations as necessary regarding CMC regulatory issues. Assessment of change controls and determining impact on regulatory submissions. Participate in providing regulatory-CMC strategies that integrate with company objectives for effective decision-making. Perform regulatory CMC activities for assigned products for US and EU as required. Tracking FDA CMC commitments and drafting CMC responses to FDA/health authorities as assigned. Review of other Module sections of the regulatory filings, various site quality documentation, preparation of cover letters, responses to FDA information requests as needed. Prepare and maintain regulatory MS project schedules & timeline tracking for regulatory CMC activities & deliverables. Develop and communicate regulatory support, review acceptability of documents for submission with the goal of achieving timelines and milestones. Apply knowledge of regulatory requirements to the review of scientific documentation, labeling and analytical data, and clinical reports intended for submission to regulatory authorities as per sponsor/company requests. Assist with ensuring company compliance with all applicable global regulatory guidance, regulations, and laws.CMC Technical Writer/Quality Assurance Consultant, (RevereIT, Client: Advaxis Inc.), NJ Jan 2017-Feb 2019 Key roles as a CMC Technical Writer:MAA Project: Responsible for designing and preparing documents as a part of MAA (Marketing Authorization Approval) regulatory submission for biotechnology-derived active substances. Design and develop Process Validation Master Plan (VMP), Process Validation and Process Verification Protocols, Tech transfer documentation to achieve FDA and EMA regulatory compliance. Design and develop General and Product Specifications, study protocols, Process comparability Protocols, SOPs, Process Validation and Process Verification Summary Reports, Developments reports, Comparability reports. Work to establish Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs). Develop, update and maintain Testing and Sampling plans, Templates for Batch Data Analysis, Stability Flat files. Coordinate with overseas Contract Manufacturing Organizations (CMOs) and prepare Tech transfer documentation for establishment of Commercial Drug Process at the CMO. Assist in developing, review and editing CMC Module 3 sections of the MAA submission for Drug Substance (3.2.S) and Drug Product (3.2.P). Preparation of amendments, annual reports to regulatory filings, drafting responses to EMA assessments and addendums to documents. Work closely with Manufacturing, Quality and Regulatory teams to ensure quality compliance of submission information with regulatory requirements. Addressing unique requirements for specific drug manufacturing process by aligning with Q8/Q9/Q10/Q11 guidance. Review associated documents like Clinical, Commercial and Reference Standard Specification documents, Validation Project Plan, Batch Production Records, Master Batch Records, CoA (Certificate of Analysis), SoA (Summary of Analysis), Final Reports. Edit, Update and review associated documentation and analyze gaps for harmonization of information. Perform Risk Management, Risk Analysis Activities and Impact Assessment. Prepare Deviation reports and Propose Corrective Action for the Process validation and Verification studies and for associated documentation. Good understanding and ability to interpret and navigate FDA, EMA, ICH, ISO regulatory requirements, guidance documents. Good understanding of eCTD format of regulatory submission. IND Project: Prepare various Module 3 sections of the IND, preparation of amendments, annual reports to regulatory filings, drafting responses to FDA deficiency reviews, Information Requests and other technical, supporting documents. Analysis of Operating parameters, in-process and release testing results to assess the process to support Clinical Phase- appropriate GMP compliant manufacturing and testing operations. Perform gap analysis of the process, manufacturing/testing operations, production documentation to ensure compliance with information in IND submission. Identify potential gaps to be addressed in Amendments/Annual reports to the original IND. Perform risk and impact assessments to identify potential risks and analyze impact of risks/gaps on the process, product and regulatory filings.Key roles as a Quality Assurance Consultant: Develop and prepare Site Master File for Advaxis prior to the commencement of on-site manufacturing/production. Addressing regional/national regulatory requirements and aligning with EudraGMP and PIC/S guidance. Identifying potential gaps in the internal procedures/policy documents versus GMP requirements for the site and working closely with the Quality Assurance and cross-functional departments in resolving gaps and ensuring compliance. Performing Assessment for the definition of GMP space within the facility and the start of API production for the various drug manufacturing processes in accordance with ICH Q7. Work on Risk assessment and develop measures for minimization of TSE/BSE transmission for various products. Assist in performing internal audits, OOS review, Root cause analysis, trending, Investigations, Deviation Management and CAPA. Review, update and approve documentation as required.Teaching Assistant for Biochemistry Course & Laboratory, UTD, TX Jan 2015-May 2016 Grading exams, problem sets, weekly lab reports. Conducting weekly review sessions and workshop classes to help undergraduate students review Biochemistry concepts and principles. Pre-lab preparation, assisting in experiments in the lab.Internship in BioLim Biosolutions (P) Ltd, Chennai, India Feb 2014-May 2014 Genotoxic and mutational studies in Drosophila melanogaster under the effect of the azo dye methyl orange. Performed Drosophila culture, maintenance and methyl orange exposure studies. RESEARCH EXPERIENCE:Graduate Research Student in Molecular and Cell Biology Lab, UTD, TX July 2015-Aug 2016 Research work and design of experiments to study Heme uptake and role in cancer cells. Trained in performing cytotoxic, proliferation and cell-based assays, using immunofluorescent microscopy, affinity chromatography, xenograft sectioning, IHC and western blot. Preparation of SOPs, Study Reports, White papers, Research articles, Thesis and Summary reports. Understanding of Good Documentation, Good Laboratory and Good Clinical Practices. |
