ASHOK KUMAR SUTHAR
Ahmedabad,
Summary
- A seasoned Regulatory Affairs professional with over 14 years of expertise, specializing in global regulatory checks, drug master file reviews, and strategic regulatory planning and audits.
- Adept in CMC review, minimizing critical deficiencies, crafting quality responses to agencies, and leading teams with precision to achieve management goals.
- Demonstrate extensive knowledge of Regulatory Guidelines, ensuring meticulous adherence to filings in diverse markets and aligning products with market requirements.
- Exhibit strong cross-functional coordination skills, liaising seamlessly with R&D, product development, and operation/quality functions for prompt and accurate documentation.
- Sound knowledge of Analytical, Quality Assurance, Formulation Processes, US FDA’s GDUFA processes and electronic activities, and Technology Transfer activities.
- An effective communicator skilled in relationship management, with analytical prowess, a detail-oriented approach, and a flexible attitude.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Manager (Regulatory Affairs)
Micro Labs Ltd.
Bengaluru
04.2019 - Current
- Steer error-free regulatory submissions through meticulous checks, overseeing Global Regulatory Affairs precisely
- Validate product formula and label compliance, securing necessary licenses before product release to guarantee regulatory acceptance
- Manage and facilitate amendments and post-approval variations (CBE-0, CBE-30, and PAS) for the US, ensuring compliance and timely execution
- Collaborate with QC and R&D departments, ensuring timely inclusion of essential technical documents (batch records, specifications, analytical methods, validation reports, and stability data) in registration dossiers
- Respond promptly to regulatory queries from various agencies, demonstrating agility and adherence to stipulated timelines
- Integrate regulatory strategies, from development to submission, including FDA-controlled correspondence, dose-weight proportionality, trade dress, specifications, IIG, packaging, stability requisites, and DD
- Assess proposed CMC changes for accuracy and completeness, interpret CMC regulations, develop strategies, evaluate risks, and create backup plans
- Authorize technology transfer documents for submission and variation batches, ensuring accuracy and compliance
- Oversee and uphold regulatory strategies, tools, timelines, and dashboards, ensuring streamlined operations
- Maintain meticulous archives of all regulatory permissions, ensuring a comprehensive and accessible record
- Demonstrate adept multitasking in a fast-paced environment, prioritizing tasks to meet objectives
- Collaborate with R&D and Operations teams, seamlessly integrating regulatory strategies into site projects
- Stay informed on updates related to regulatory requirements and implement necessary changes promptly
- Leverage extensive experience in eCTD and oversee life cycle management activities effectively
- Effectively communicate goals to team members, clarifying their roles in achieving organizational objectives
- Prepare well-crafted responses to legal and technical queries raised by Regulatory authorities, demonstrating a proactive approach to compliance
- Ensure staff motivation, monitoring, and measurement align with organizational targets and performance standards
- Foster team retention, nurturing, and training, contributing to progressive value addition within the team.
Deputy Manager (Regulatory Affairs)
Cipla Ltd.
Mumbai
12.2016 - 04.2019
- Managed post-approval submissions (supplements / variations, annual reports) for major global regulatory affairs, ensuring zero defects
- Responded promptly to deficiencies in submitted supplements and submitted variations for other Rest of the World (RoW) countries based on business priorities
- Collaborated with QC and R&D departments, ensuring timely inclusion of essential technical documents (batch records, specifications, analytical methods, validation reports, and stability data) in registration dossiers
- Evaluated change controls and conducted regulatory assessments through system software for the global market
- Rendered technical and regulatory support to business, internal Cross-Functional Teams (CFTs), and external Drug Master File (DMF) suppliers/customers
- Ensured smooth functioning throughout the product life cycle, including maintenance of databases and TrackWise entries
- Efficiently created compliant product information flyers and marketing materials, collaborating with Regulations to ensure accuracy and adherence to standards.
Assistant Manager (Regulatory Affairs ANDA Team)
USV Private Ltd.
Mumbai
08.2016 - 11.2016
- Expertly navigated ANDA deficiencies and seamlessly managed post-approval regulatory activities, showcasing adept regulatory affairs skills
- Orchestrated seamless coordination with internal and external stakeholders
- Provided invaluable support to subordinates and colleagues, particularly in navigating the intricate landscape of regulatory and technical operational aspects, fostering a collaborative and efficient work environment.
Asst. Manager (International Regulatory Affairs – US Market)
Cadila Healthcare Ltd. (Zydus Group)
Ahmedabad
05.2013 - 08.2016
- Expertly conducted technical reviews of documents and compiled 505(b)(2) NDA / ANDAs / Amendments in eCTD format, covering both Topical and Solid Oral formulations
- Compiled and reviewed post-approval supplements, including site transfers, PAS, CBE-30, and CBE-0, along with annual reports, ensuring meticulous documentation filing
- Participated in Agency Audits, contributed to CAPA formulation, and conducted diligent dossier reviews for regulatory compliance and quality enhancement
- Reviewed Type II API DMFs for assigned projects from an ANDA perspective, coordinating with API suppliers for additional regulatory requirements
- Timely addressed deficiencies raised by USFDA, including Screening, ECD, IR, and CRL, demonstrating a proactive approach to regulatory compliance
- Evolved Regulatory Affairs scenarios, developing innovative approaches to ensure alignment with business goals
- Efficiently prepared and maintained a comprehensive database for ANDAs and deficiency responses, ensuring accurate record-keeping
- Ensured tracking and timely submission of final approval requests to USFDA for tentatively approved ANDAs
- Formulated regulatory strategy notes based on reference product information, providing a strategic submission approach
- Prepared and submitted controlled correspondences for Q1/Q2, IIG, and other relevant requirements as needed
- Coordinated with internal and external stakeholders, including agents and suppliers, to request and provide data, resolving issues pertinent to submissions effectively.
Scientist-I (Development Regulatory Centre)
Sandoz Pvt. Ltd.
Navi Mumbai
04.2011 - 04.2013
- Efficiently managed regulatory submissions and addressed deficiencies across diverse scopes, including the US, EU, CA, JP, Semi-Regulated, and RoW countries
- Expertly handled post-approval supplements, ensuring meticulous document maintenance and proactive management of the post-approval life cycle
- Evaluated change controls to assign appropriate regulatory determinations for post-approval changes, ensuring compliance with regulatory standards
- Assessed prototype documents and technical documentation packages for compiling comprehensive dossiers, maintaining a high standard of regulatory documentation
- Coordinated with development and other functions to provide timely responses to deficiency letters, fostering effective cross-functional collaboration
- Operated and maintained the registration database (RegDB) and variation database (VarDB) via SAP, ensuring accurate and up-to-date regulatory information
- Actively supported DRA initiatives and participated in project meetings, contributing to the success and alignment of regulatory activities with organizational goals.
Regulatory Associate (Regulatory Affairs)
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad
12.2009 - 12.2010
- Meticulously prepared and compiled ANDA submissions in eCTD format, specializing in solid oral dose forms for the discerning US market
- Conducted comprehensive reviews of documents sourced from ARD, QA, QC, and R&D departments, ensuring a thorough and accurate submission package
- Crafted clear and accessible product labels and patient information leaflets, contributing to effective communication and regulatory compliance.
Education
M. Pharm. (QA) -
Lachoo Memorial College of Science &Technology
03.2009
B. Pharm. -
B.K. Modi Govt. Pharmacy College
06.2006
Skills
- Global Regulatory Affairs
- Technical Writing
- Reviewing & Filing Regulatory Submissions
- Amendment & Lifecycle Management
- Resolve & Respond to Regulatory Queries
- Analytical & Critical Thinking
- WHO/ANDA/NDA 505b2 Submissions
- Handling WHO/ANDA/NDA Deficiencies
- Process Development
- Control Strategies
- CAPA Formulation
- Regulatory Audit & Compliance
- Due Diligence of Dossiers
- Interpersonal Skills
- Problem-Solving
- Team Leadership/Decision-Making
- Stakeholder Collaboration
- Cross-Functional Collaboration
- Organizational Improvement
- Experience in Regulatory Software viz PharmaReady, Educe, IBM SCORE application, and ISI writer & toolbox for compilation & maintenance of the submitted dossier & documents
- MS Office package, Acrobat, Photoshop Software and Knowledge of web browsing
Certification
- As Trainee Assistant in Analytical Development Laboratory at “Torrent Research Centre”, Gandhinagar, January 2008 - August 2008 [M. Pharm. academic dissertation work].
- Undergone training for three months at “Lincoln Pharmaceutical Ltd”, Ahmedabad.
Accomplishments
- Received “Star Contributor for the Year 2022-23” at Micro Labs Ltd
- Been a part of major post-approval activities and approved 3-4 applications within a month before the TAT given in Micro Labs.
- Recognized with a “Kshitij Recognition Award” at Cadila Healthcare Ltd. (Zydus Group)
- Honored “Development Award for Promising Young Executive”- Sandoz Pvt. Ltd
- Awarded “SPOT award (Pearl)” at Sandoz Pvt. Ltd for JP regulatory filing accomplishment
- 2nd Rank in the final semester of M. Pharm. (QA) at Rajasthan University of Health Sciences, Jaipur
- Qualified GATE-2006 held by IIT, Kharagpur, with a 97.01 percentile
Personal Information
Date of Birth: 05 June 1985
Languages
- English
- Hindi
- Rajasthani
- Gujarati
Timeline
Senior Manager (Regulatory Affairs)
Micro Labs Ltd.
04.2019 - Current
Deputy Manager (Regulatory Affairs)
Cipla Ltd.
12.2016 - 04.2019
Assistant Manager (Regulatory Affairs ANDA Team)
USV Private Ltd.
08.2016 - 11.2016
Asst. Manager (International Regulatory Affairs – US Market)
Cadila Healthcare Ltd. (Zydus Group)
05.2013 - 08.2016
Scientist-I (Development Regulatory Centre)
Sandoz Pvt. Ltd.
04.2011 - 04.2013
Regulatory Associate (Regulatory Affairs)
Amneal Pharmaceuticals Pvt. Ltd.
12.2009 - 12.2010
M. Pharm. (QA) -
Lachoo Memorial College of Science &Technology
B. Pharm. -
B.K. Modi Govt. Pharmacy College
Similar Profiles
Mojes Paul VALLEMojes Paul VALLE
Territory Sales Representative (SYNAPSE) at Micro Labs Ltd APITerritory Sales Representative (SYNAPSE) at Micro Labs Ltd API
Pavani BodapatiPavani Bodapati
Quality-assurance-specialist at Micro Labs LimitedQuality-assurance-specialist at Micro Labs Limited
ROHIT SINGHROHIT SINGH
Regional Manager at Micro Labs LtdRegional Manager at Micro Labs Ltd