Rima Gupta
Morris Plains,USA
Summary
Pharmaceutical professional with nearly 15 years of experience in Regulatory Affairs and Quality Compliance. Experienced in managing projects within regulatory and compliance frameworks and working collaboratively in various environments. Applies regulatory knowledge, compliance skills, and cross-functional teamwork to contribute to organizational objectives.
Overview
15
15
years of professional experience
Work History
Manager, Regulatory Affairs
Torrent Pharma Inc.
01.2019 - 02.2025
- Led regulatory strategy and submission planning for ANDA and NDA 505(b)(2) applications, ensuring compliance and timely approvals.
- Oversaw post-approval change management, determining appropriate regulatory pathways for amendments, supplements, and annual reporting.
- Collaborated with global teams to align on regulatory standards and maintained clear communication with internal and external stakeholders.
- Tracked new regulatory changes, assessed their impact, and shared updates with teams such as R&D, Quality, and Operations to support timely compliance.
- Supported regulatory due diligence activities for licensing, partnerships, and acquisitions.
- Oversaw regulatory commitments during product launches by coordinating critical activities such as drug listing, securing Puerto Rico registrations, drafting USDA and End User letters, and managing PLAIR submissions to ensure timely compliance and successful market entry.
- Managed state distribution licenses to ensure compliance with local regulations and supported smooth business operations.
- Supported and guided junior regulatory team members, encouraging knowledge sharing and continuous learning.
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Defined clear targets and objectives and communicated to other team members.
Associate - Regulatory Affairs
Cosette Pharma (Formerly G&W Laboratories, Inc.)
12.2015 - 01.2019
- Prepared and submitted electronic regulatory documents—including ANDAs, Amendments, Supplements, and Annual Reports—ensuring accuracy and regulatory compliance to support timely approvals.
- Reviewed CMC content, labeling, and other technical documents to confirm alignment with FDA regulations.
- Collaborated with cross-functional teams to resolve regulatory issues and complete submissions on schedule.
- Assessed regulatory implications of CMC changes and contributed to strategy development for continued compliance.
- Helped prepare and review U.S. labeling components such as prescribing information, medication guides, and packaging artwork.
Compliance Writer - Quality
Cosette Pharma (Formerly G&W Laboratories, Inc.)
11.2013 - 01.2015
- Initiated and managed change control requests, coordinating with cross-functional teams for effective implementation.
- Revised Standard Operating Procedures (SOPs) to reflect new processes and industry best practices.
- Provided essential documentation to Regulatory Affairs for timely and accurate agency submissions.
- Supported laboratory investigations, identifying root causes and implementing corrective actions for quality issues.
- Performed process mapping for the TrackWise system, improving workflow efficiency and traceability.
Technical Writer - Product Development
Lupin Pharmaceuticals (Formerly Novel Laboratories, Inc.)
11.2011 - 10.2013
- Created and maintained crucial documents, such as Pharmaceutical Development Reports (PDRs), Master and Packaging Batch Records, and Process Validation Protocols, to support each stage of product development.
- Worked as a subject matter expert (SME) with Regulatory Affairs to resolve agency deficiencies and update master documentation.
- Coordinated with AR&D, Product Development, QA, and Regulatory Affairs to compile and review CMC sections for submissions.
- Updated SOPs to ensure compliance with manufacturing and quality standards.
- Managed change controls from initiation to closure, meeting all regulatory and internal requirements.
Scientist I - Quality Control
Amneal Pharmaceuticals, Inc.
02.2010 - 05.2011
- Conducted assays, content uniformity, and dissolution tests for in-process materials, stability studies, and finished product release.
- Executed related substance testing per USP and in-house methods, using HPLC systems (Waters, Agilent, Shimadzu) and Empower 2.0 software.
- Documented analytical results and certificates of analysis in compliance with GMP and internal SOPs.
Education
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology
Hoboken, NJ01.2010
Bachelor of Science -
Rajiv Gandhi University of Health Sciences
Bangalore, India12.2006
Skills
- TrackWise expertise
- PharmaReady expertise
- Proficient in Microsoft Office Suite
- Team leadership
Affiliations
Member, Regulatory Affairs Professionals Society (RAPS)
Core Competencies
- Regulatory Submissions: ANDAs
- Product Lifecycle Management
- Health Authority Interactions (FDA)
- Labeling Review & eCTD Proficiency
- Regulatory Intelligence & Risk Assessment
- Project Management & Cross-Functional Collaboration
- GxP Compliance & Quality Systems
Timeline
Manager, Regulatory Affairs
Torrent Pharma Inc.
01.2019 - 02.2025
Associate - Regulatory Affairs
Cosette Pharma (Formerly G&W Laboratories, Inc.)
12.2015 - 01.2019
Compliance Writer - Quality
Cosette Pharma (Formerly G&W Laboratories, Inc.)
11.2013 - 01.2015
Technical Writer - Product Development
Lupin Pharmaceuticals (Formerly Novel Laboratories, Inc.)
11.2011 - 10.2013
Scientist I - Quality Control
Amneal Pharmaceuticals, Inc.
02.2010 - 05.2011
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology
Bachelor of Science -
Rajiv Gandhi University of Health Sciences