Vishal Dhanawade
Thane, Maharashtra
Summary
Experienced Regulatory Affairs professional with a proven track record of successfully managing multiple ANDA applications for various dosage forms viz.Solid Orals including Modified and Immediate Release Tablet/Capsules, Topicals and Rectal Vaginal Drug Delivery products, achieving three first-cycle approvals. Skilled in handling complex, multi-module activities for global regulatory affairs, ensuring business continuity and product lifecycle management. Expertise spans new submissions and product lifecycle management, with a strong focus on delivering high-quality regulatory submissions to US and other advanced markets.
Overview
14
14
years of professional experience
Work History
Manager -Regulatory Affairs and Business Continuit
Sun Pharmaceutical Industries Limited
02.2022 - Current
- Compiled and reviewed dossiers for submissions in US, Europe, and Canada markets, and responded to deficiencies to secure approval.
- Post-Approval Changes Management: Managed post-approval changes for products in US, Europe, Australia, and Canada markets, including:
- - US: Annual Reports (AR), Changes Being Effected (CBE-0, CBE-30), and Prior Approval Supplements (PAS)
- - Europe: Type IA, IB, and II Variations
- - Australia: Notifications and Category 3 changes
- - Canada: Level 1 and Level 2 changes
- - Conducted change assessments and change control management Via Trackwise System, defined regulatory strategies, prepared submission packages, and tracked regulatory submissions.
- Communicated changes to internal stakeholders (e.g., manufacturing, quality) and external stakeholders (e.g., FDA, customers).
- Supported business continuity activities through coordination with various stakeholders.
- Ensured regulatory compliance from product development to commercialization.
- Coordinated and collaborated with cross-functional teams in R&D, Project Management, manufacturing locations, 3rd party contract manufacturers, and other relevant stakeholders.
- Clearly communicated regulatory requirements to stakeholders.
- Provided on-the-job training to subordinates and overview of their activities.
- Kept updated with current regulatory guidance documents and requirements.
- Led development and implementation of RIMS-Amplexor for departmental functions extension to eCTD submissions and electronic labelling.
Assistant Manager- Regulatory Affairs
Encube Ethicals Private Limited
09.2020 - 02.2022
- Developed and implemented regulatory strategies for filing ANDAs for topical dosage forms, including gels, creams, solutions, and ointments.
- Managed ANDA submissions, including planning, review, and ensuring readiness for FDA submission.
- Handled post-approval changes, including CBE-0, CBE-30, and PAS submissions.
- Responded to FDA deficiencies, including initial filing review comments, information request letters, discipline review letters, and complete response letters.
- Ensured compliance with FDA regulations, including GDUFA requirements and metrics to achieve first-cycle approvals.
- Provided regulatory guidance and strategic input for topical dosage form development projects.
- Coordinated with cross-functional teams to deliver quality projects on time.
- Trained manufacturing sites on FDA guidance and regulatory requirements.
- Monitored FDA guidance, regulatory databases, and industry trends to ensure regulatory compliance.
- Regulatory Expertise
- -eCTD Submission: Compiled and submitted -ANDAs in eCTD format, including CMC and labeling sections.
- -Labeling Management: Managed labeling requirements, including SPL and PIL.
- - Change Control and Deviation Management: Handled change controls and deviations received from facilities.
- - Annual Updates and Renewals: Responsible for annual updates and renewals of self-identification, establishment registration, and drug listing activities.
Executive -Regulatory Affairs
Bliss GVS Pharmaceutical Limited
06.2017 - 09.2020
- Established and led the Regulatory Affairs (RA) department for US and EU environments.
- Developed regulatory strategies and plans for new project development, including ANDA, OTC, and WHO pre-qualification submissions.
- Managed GDUFA electronic modules, facility registration, and labeling requirements.
- Reviewed and approved CMC documents, QMS documents, and stability protocols.
- Developed product strategies for US, EU, and WHO markets, and prepared responses to regulatory deficiencies.
- Coordinated with cross-functional teams, provided training and guidance to junior colleagues, and tracked new product development and regulatory status.
Executive -Regulatory Affairs
Umedica Laboratories Private Limited
12.2013 - 06.2017
- Compilation and submission of ANDA in eCTD format as per eCTD and SPL guidelines to US-FDA.
- Analyzing of deficiency, designing corrective action plan with stakeholders, ensuring receipt of the required documents and compilation and submission of responses.
- Review of DMF’s (Type II) and suppliers or vendors documents by applying all USFDA guidelines and as per the ANDA checklist.
- Review of change control received from respective stake holder and discusses with superior and team.
- Ensuring preparation and review of documentation, regulatory information for new development products according to the requirements of Guidelines of USFDA, ICH- Guidelines and other required guidelines.
- Well acquainted with the eCTD and SPL of Pharma Ready and Knowledge Net Publishing and ESG submission procedure.
- Established Electronic Submission Gateway (ESG) and installation of digital signature from Global Sign for US submission and GDUFA compliance of DUNS number, self- identification and Establishment Registration, Facility Fees of manufacturing facility.
- Preparation and maintained of different Regulatory Database.
Officer - Quality Assurance
Ally Pharma Options Private Limited
04.2011 - 12.2013
- Prepared and compiled submission documents for registration dossiers for non-regulated markets.
- Managed online applications for manufacturing licenses and Certificates of Pharmaceutical Product (COPP).
- Prepared and reviewed QMS-related documents, including process validation, stability studies, and deviations control, change control, Annual product review.
- Conducted internal calibration of equipment and in-process checks for various products and self-inspection activities.
- Co-ordinated internal quality audits and reviewed vendor records.
- Issued and managed deviations and change controls.
Education
Master Of Pharmacy - Quality Assurance Techniques
Ashokrao Mane College of Pharmacy
Peth Vadagaon, Maharashtra 07.2016
Bachelor Of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy
Karad, Maharashtra 06.2010
Higher Secondary Certificate - Science
Vidyamandir Highschool & Junior College
Islampur, Maharashtra 06.2005
Secondary School Certificate -
Karmaveer Bhaurao Patil Highschool And Jr College
Aitawade BK., Maharashtra 06.2003
Skills
- Regulatory Affairs
- Project Management
- Communication
- Collaboration
- Training and Development
- Process Improvement
- CMC (Chemistry Manufacturing Control) Technical Expertise
- Leadership
- Quality Focus
- eCTD submission and electronic labelling
- SOP Development
- Process Documentation
- Change Control Management
- Product Lifecycle management
- Drug Listing
- Risk Management
- QMS
- Pharmaceutical Validation
Languages
English
Advanced (C1)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Personal Information
Date of Birth : 16th May. 1988
Sex and Marital Status : Male, Married
Children : 1
Languages Known : English, Hindi, Marathi
Passport Availability : Yes
Hobbies : Painting, Reading, Writing, Playing chess, Travelling
Industrial References
1. Mr. Rakesh Pokharana (General Manager, Global Regulatory Affairs, M/s. Encube Ethicals Private Limited, Mumbai.
Contact: +91 98863 85000
2. Mr. Anurag Bansal (General Manager, Regulatory Affairs and Business Continuity, Sun Pharmaceutical Industries Limited, Gurgaon Haryana.
Contact :+91 98104 98520
Timeline
Manager -Regulatory Affairs and Business Continuit
Sun Pharmaceutical Industries Limited
02.2022 - Current
Assistant Manager- Regulatory Affairs
Encube Ethicals Private Limited
09.2020 - 02.2022
Executive -Regulatory Affairs
Bliss GVS Pharmaceutical Limited
06.2017 - 09.2020
Executive -Regulatory Affairs
Umedica Laboratories Private Limited
12.2013 - 06.2017
Officer - Quality Assurance
Ally Pharma Options Private Limited
04.2011 - 12.2013
Master Of Pharmacy - Quality Assurance Techniques
Ashokrao Mane College of Pharmacy
Bachelor Of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy
Higher Secondary Certificate - Science
Vidyamandir Highschool & Junior College
Secondary School Certificate -
Karmaveer Bhaurao Patil Highschool And Jr College
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