THARAKA RAMA
Senior Regulatory Science professional
Hyderabad
Summary
Dedicated Regulatory science professional, working on Biosimilars/Biologics/ATMPs with 17+ years of rich and diversified experience in Regulatory science, analytical R&D, and analytical QC.
Overview
17
17
years of professional experience
Work History
Senior Manager -Regulatory CMC Lead
IQVIA
01.2022 - Current
- CMC Regulatory Affairs | Biologics | Cell & Gene therapy | mAbs ATMPs GTMPs
Client Focus, Risk mitigation strategies.
• Preparation and submission of regulatory filings with relevant health authorities such as US FDA, HC and European regulatory authorities. BLA/MAA/IMPD Authoring, review, Gap assessments in terms of CMC.
• Leading multidisciplinary teams in the development, authoring and review of high-quality Chemistry, Manufacturing and Controls (CMC) documents (small molecules and biologics) for regulatory applications.
• Responsible for regulatory strategy and leading or providing oversight for
the preparation, review and submission of documents for Investigational New Drug Applications (INDs), Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Investigational Device Exemptions (IDEs) including post marketing activities to United States (US) Food and Drug Administration (FDA), Health Canada (HC) and European as well as other regulatory authorities.
• Provides regulatory advice to multidisciplinary teams on the regulatory requirements to support the preparation, submission, and maintenance of regulatory filings, including support for meetings, with relevant health authorities such as US FDA, HC and European regulatory authorities.
• Maintains effective communication with customers and project teams through oral and written correspondence.
• Reports progress, challenges, issues, actions and provides support for resolutions and risk mitigation as appropriate.
• Acts as a liaison between the sponsor and cross-functional teams for complex global projects with multiple countries’ and in-country specialists’ involvement.
• Maintains current knowledge of FDA, HC and/or European regulations, and GCP and ICH Guidelines for clinical research.
• Participates in business development activities to grow Biotech business. - Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Implemented and developed operational standards, policies and procedures.
Manager- Regulatory Affairs- Biosimilars
Hetero Biopharma Limited
4 2019 - 1 2022
- CMC content development &preparation of paper-based and as well as e-CTD-related CMC packages, Dossiers for Biosimilars (Rituximab, Bevacizumab, Adalimumab, Trastuzumab, D'poetin, and Sputnik-V Vaccine)
- Authoring & review CMC content in compliance with regulatory guidance's ICH, FDA, EMEA, and IMPD
- Preparation of scientific briefing packages concerning CMC content as per regulated formats
- Providing query responses and justifications for regulatory queries including regulated market and ROW market
- Making road maps, regulatory strategies, risk mitigation strategies, and coordination among cross-functional teams like QC, QA, manufacturing, and analytical R&D along with project management.
Associate Manager- Regulatory Sciences-Biosimilars
Biocon Research Limited
06.2018 - 04.2019
- Filing Market Registration Applications for Insulin analogues and MAbs (Monoclonal Antibody) for a regulated market
- (FDA, EMEA, JAPAN, etc.,)
- CMC expert, CMC content development &preparation of paper-based and as well as eCTD-related CMC packages, Dossiers for Biosimilars
- Review of CMC content in compliance with regulatory guidance's ICH, FDA, EMEA, and IMPD
- Preparation of scientific briefing packages concerning CMC content as per regulated formats
- Follow up with internal departments (Analytical R&D, QC, Manufacturing departments) for gathering and discussing the content, queries, and responses for scientific advice and dossiers.
Principal Scientist -Quality Control
Kemwell Biopharma Pvt LTD.
10.2017 - 06.2018
- Lead a team of scientists who plays a crucial role in the following technical activities- Analytical Method Validations, Tech Transfer, and Batch/Lot release/Stability analysis support
- HPLC Instrumentation techniques for manufacturing Monoclonal Antibodies
- Facing regulatory & sponsor audits
- GMP Batch Releases and In-process support, Raw Data and Laboratory records review, COA preparation, and approval.
Manager, QC (Analytical)
Biological E Limited
10.2015 - 10.2017
- Analytical Method Validations and Tech Transfer Batch release and stability for Pneumococcal Conjugate Vaccine
- (14 valent)
- Leading a team conducting Method qualifications/Validation of analytical methods/assays to test product quality at various stages of product development
- Supervising a team of scientists involved in method validations, Process support, product (DS, DP) lot release, stability studies, and tech transfer of validated methods currently
- Analytical Method Transfer between R&D and QC
- GMP Batch Releases and In-process support, Raw Data and Laboratory records review, COA preparation, and approval
- Analytical method Validations (Protocol preparation, Execution and Report preparation as per Q2R1) Stability Studies AS per Q5C.
Assistant Manager, QC, Biologics Department
Syngene International Ltd, (A Biocon Company)
03.2013 - 10.2015
- Responsible for conducting analytical assays to test product quality at various stages of product development
- Supervising a team of scientists involved in Process support, product (DS, DP) lot release, stability studies, and tech transfer of validated methods for analyzing biosimilar/Biologics/Mabs/Polymer peptides, therapeutic peptides hormones, etc
- From clients inside and outside India
- Conducting of LCMS/MS, MALDI-TOF/TOF (Intact Mass, Average M.Wt of Polymers, N and C-Terminal sequence confirmation), biochemical, HPLC (RP, SEC, and IEX), Electrophoresis (SDS, ICE) Ligand Binding Assays (ELISA), and Cell-based assays for testing biopharmaceutical product quality in Quality Control department
- Conducting Physiochemical analysis of Biotherapeutics by HPLC (RP, SEC, IEX), worked on MAbs, Para thyroid Hormone, Physiocrine Proteins, Glatiramer Acetate, Erythropoietin, Interferons, etc
- Documentation as per GMP, and drafting and reviewing protocols, reports of biopharmaceutical analytical method development, Method validation/qualification, analytical method transfer, stability studies scientific manuscripts
- Monitoring regular compliance of all instruments, and systems as per c GMP/GLP
- Attending Client meetings, teleconferences, and Project review meetings to understand and meet client requirements, and managing the team to meet the same.
Research Associate in Bioanalytical Research Unit
GVK Biosciences Pvt Ltd
09.2008 - 02.2013
- Diligently assisting Bioanalytical Chemists in handling & Calibration of LC-MS/MS
- Effectively involved in the verification of study-related data
- Effectively contributing to method development and method validation of various molecules
- Preparation of protocols and reports of the validation projects
- Preparation of method sops
- Preparing Protocols for Method Validation
- Preparing Study and Method Validation Reports for BA/BE Clinical studies
- Checking of Chromatograms Raw data files
- Faced different Audits Conducted by FDA, GLP Indian, and the Netherlands, and various facility audits and Sponsor Audits.
Bioanalytical Chemist, Bioanalytical Research Division
LOTUS LABS PVT LTD
05.2007 - 08.2008
- Effectively involved in the verification of study-related data
- Effectively contributing to method development and method validation of various molecules
- Literature survey of various drug molecules.
Education
Ph.D. in Biotechnology -
Acharya Nagarjuna University
Guntur, Andhra PradeshM.Phil. in Biotechnology - undefined
Vinayaka Missions University
Salem, Tamil NaduMaster of Science in Biotechnology - undefined
Periyar University
Salem, Tamil NaduBachelor of Science - Biochemistry, Chemistry, Microbiology
Sri Venkateswara University
Tirupathi, Andhra PradeshSkills
CMC Module 2&3 Authoring, Review, Biologics, Cell and Gene Therapy, Biosimilars, Monoclonal antibodies, ADCs
Accomplishments
- IQVIA IMPACT GOLD Award for the best performance in MAA&BLA preparation.
- Best employee awards twice for outstanding performance in GVK Bio.
Teachingexperience
- ADITYA Degree & P.G College, Rajahmundry, 06/2006 - 01/2007, Biotechnology and Immunology
- Dr. B.V. Raju Institute of Computer Education, Bhimavaram, 07/2004 - 06/2006, Biotechnology and Immunology
- S.D.H.R. PG College, Rayachoty, 06/2002 - 06/2004, Biochemistry and Molecular biology
Personal Information
- Date of Birth: 06/01/1980
- Marital Status: Married
Timeline
Senior Manager -Regulatory CMC Lead
IQVIA
01.2022 - Current
Associate Manager- Regulatory Sciences-Biosimilars
Biocon Research Limited
06.2018 - 04.2019
Principal Scientist -Quality Control
Kemwell Biopharma Pvt LTD.
10.2017 - 06.2018
Manager, QC (Analytical)
Biological E Limited
10.2015 - 10.2017
Assistant Manager, QC, Biologics Department
Syngene International Ltd, (A Biocon Company)
03.2013 - 10.2015
Research Associate in Bioanalytical Research Unit
GVK Biosciences Pvt Ltd
09.2008 - 02.2013
Bioanalytical Chemist, Bioanalytical Research Division
LOTUS LABS PVT LTD
05.2007 - 08.2008
Manager- Regulatory Affairs- Biosimilars
Hetero Biopharma Limited
4 2019 - 1 2022
Ph.D. in Biotechnology -
Acharya Nagarjuna University
M.Phil. in Biotechnology - undefined
Vinayaka Missions University
Master of Science in Biotechnology - undefined
Periyar University
Bachelor of Science - Biochemistry, Chemistry, Microbiology
Sri Venkateswara University
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