Chandrashekhar R. Pal
Vasai
Summary
Specialist, Regulatory Affairs - US manages USFDA post-approval submissions, including Annual Reports, PADERs, labeling supplements, and CMC Supplements, communication with FDA. Leads eCTD publishing, SPL maintenance, and regulatory support for marketing authorization transfers, technology transfers, and change-of-ownership projects. Partners with Quality, Technical Operations, Medical Affairs, Legal, and external manufacturers to keep products compliant and inspection ready.
Overview
3
3
Languages
12
12
years of professional experience
Work History
Specialist, Regulatory Affairs - US
Advanz Pharma (Formerly Concordia International)
11.2016 - Current
- oversee USFDA post-approval regulatory submissions comprising annual reports, PADERS, labeling, and CMC supplements.
- Establish and apply regulatory strategies for commercial product portfolios throughout US, Canada, LATAM, and APAC markets.
- Operate as subject matter expert (SME) regarding US regulatory requirements, managing labeling compliance and SPL submissions.
- contributed to core group team overseeing Veeva RIMs system and Veeva QMS deployment.
- Manage and present eCTD sequences to USFDA and Health Canada through Extedo publishing systems.
- Managed marketing authorization transfers for product acquisitions and change of ownership projects. Oversaw integration of portfolios to ensure seamless transitions. Coordinated regulatory compliance during product acquisition processes. Streamlined project workflows to enhance efficiency in portfolio management.
- manage technology transfer efforts, API source updates, and manufacturing site transformations.
- review CMC documentation including specifications, analytical methods, validation reports, stability data, impurity assessments, and DMFs.
- Formulate responses to health authority deficiencies information requests and regulatory inquiries.
- Manage SPL submissions, ensuring Dailymed maintenance and labeling compliance.
- Engage with quality assurance, technical operations, medical affairs, legal personnel, CMOs, and API manufacturers to uphold regulatory compliance and business continuity.
- Guide junior regulatory professionals while enhancing process improvements and ensuring inspection readiness.
Junior Scientific Writer
Karmic Life Sciences (Cliantha Research Ltd)
11.2015 - 11.2016
- Prepared and reviewed clinical study protocols, ICFs, CRFs, and clinical study reports.
- Developed manuscripts, case studies, and case series for journal submissions.
- Created scientific presentations and CME materials for pharmaceutical clients.
Junior Medical Writer
PharmexServ Life
04.2014 - 11.2015
- Supported medical academicians in preparing research articles, posters, and case studies.
- Reviewed and translated medical research findings into thesis and scientific documentation.
Education
Master of Pharmacy - Pharmacology and Toxicology
University of Mumbai
01-2014
Skills
USFDA & Health Canada Regulatory Affairs
ROWs regulatory affairs (LATAM, and ANZ submissions)
CMC Regulatory Submissions & DMF Review
Labeling Strategy for innovator products & SPL Management
Veeva RIMS management, and eCTD Publishing (Extedo)
Health authority deficiency responses
Veeva RIMS implementation
Portfolio integration
Marketing Authorization Transfers
Technology Transfer & Change Control Management
Regulatory Process Optimization & Inspection Readiness
Artwork approval management
Regulatory intelligencee
Regulatory intelligence
Interests
Outdoor Sports, Social Work, Music, Traveling, Reading
Declaration
I hereby confirm that the above-mentioned particulars are true to the best of my knowledge. Date: Place: Mumbai Chandrashekhar R. Pal
Professional Achievements
Quarterly Excellence Awards and Hall of Fame recognition for:, Successful USFDA & Health Canada PV Audit Support, Technology Transfer and API Source Addition, Completion of Agency Labeling PLLR Commitments, Regulatory Lead for Technology Transfer Projects, Revision in Product Specification from USP, Product Acquisition & Portfolio Integration Projects, Regulatory Process Optimization & Veeva RIMS Implementation, Supply Continuity and Stock-Out Prevention Initiatives
Publications
TOPRA Regulatory Rapporteur - Published review article "EUAs – How they came into their own with COVID-19" (Nov 2021) from Advanz Pharm. (https://www.topra.org/TOPRA/TOPRA_Member/REGRAP/Public/Regulatory_Rapporteur_Issue_Detail_Public.aspx?IssueID=607805&ID=57221)
Timeline
Specialist, Regulatory Affairs - US
Advanz Pharma (Formerly Concordia International)
11.2016 - Current
Junior Scientific Writer
Karmic Life Sciences (Cliantha Research Ltd)
11.2015 - 11.2016
Junior Medical Writer
PharmexServ Life
04.2014 - 11.2015
Master of Pharmacy - Pharmacology and Toxicology
University of Mumbai