Niyati Kapadia
Alexandria,VA
Summary
Certified PMP with over 5 years of experience in Regulatory Affairs and Project Management, specializing in CMC submissions, global regulatory compliance, and cross-functional team leadership. Proven expertise in lifecycle management, risk mitigation, and regulatory strategy development. Skilled in managing complex projects, ensuring timely submission approvals, and optimizing processes for global health authority requirements.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Associate Manager, Regulatory Affairs
Granules Consumer Health Inc.
08.2023 - Current
- CMC Submission Oversight: Authored and reviewed high-quality CMC sections for ANDA submissions, supplements, and amendments
- Labeling Compliance: Managed global labeling activities, including SPL submissions and updates, ensuring compliance with FDA guidelines
- Risk Management: Conducted regulatory risk assessments, proposed mitigation strategies, and developed contingency plans for submissions
- Cross-functional Leadership: Collaborated with Quality, Technical Operations, and Supply Chain teams to align project timelines with strategic goals
- Process Optimization: Developed SOPs and Work Instructions to streamline internal regulatory procedures, enhancing efficiency
- Regulatory Strategy: Led change control meetings, categorized post-approval changes (CBE-0, CBE-30, PAS), and ensured timely FDA approvals
- Project Planning: Utilized MS Project to create integrated timelines, track deliverables, and ensure alignment with team milestones
Associate Manager, Regulatory Affairs
Granules USA, Inc.
04.2023 - 08.2023
- Global Compliance: Provided strategic guidance on regulatory requirements for ANDA submissions and lifecycle management
- Regulatory Filings: Prepared eCTD and SPL submissions, ensuring documentation accuracy and compliance with FDA standards
- Stakeholder Engagement: Communicated project status, risks, and timelines to internal and external stakeholders
- Regulatory Training: Conducted sessions to enhance team understanding of advertising, promotional material, and labeling compliance
- Change Control Management: Assessed change controls, evaluated regulatory impact, and implemented effective solutions
- Oversaw the creation of actionable project plans, incorporating insights from various stakeholders to meet targets
Regulatory Affairs Associate
Granules USA, Inc.
03.2021 - 03.2023
- Regulatory Documentation: Reviewed and submitted eCTD Modules1-5 for ANDA and post-approval changes
- Labeling Strategy: Established strategies for global labeling compliance, including SPL documentation and DailyMed updates
- Health Authority Interaction: Addressed FDA queries, including Deficiency Letters, to achieve successful approvals
- Workflow Improvement: Implemented streamlined documentation practices, boosting team efficiency by20%
- Cross-functional Collaboration: Partnered with internal departments to ensure regulatory requirements aligned with operational goals
Regulatory Affairs Associate
Spirit Pharmaceuticals LLC
07.2020 - 03.2021
- Regulatory Submissions: Authored SPL documentation and supported eCTD preparation for drug product approvals
- Quality Assurance: Conducted stability data reviews, CAPA implementation, and compliance audits
- Documentation Review: Verified technical dossiers, labeling components, and regulatory documents for accuracy
Associate Project Manager
Haffkine Biopharmaceutical Co. Ltd.
05.2017 - 07.2017
- Regulatory Compliance: Collaborated with Senior Scientists to develop dosage formulations adhering to GMP and SOPs, ensuring alignment with21 CFR regulations for drug development and submission
- Disease Management Programs: Supported the creation, monitoring, and implementation of protocols for disease management and drug utilization, integrating Corrective and Preventive Action (CAPA) strategies to enhance compliance
- Quality Assurance: Conducted Annual Reviews, site monitoring, and investigations to address regulatory issues, ensuring process improvements and compliance with FDA guidelines
- Cross-functional Collaboration: Partnered with teams across formulation, analytical sciences, and regulatory functions to streamline workflows and optimize project outcomes
- Labeling Compliance: Ensured all labeling activities met FDA regulatory requirements throughout the project lifecycle, enhancing adherence and submission accuracy
- Project Lifecycle Management: Contributed to all phases of project execution, from initiation to closure, delivering projects on time and within regulatory guidelines
Associate Manager
Saifee Hospital Pvt. Ltd.
05.2016 - 07.2016
- Stakeholder Engagement: Built and maintained relationships with physicians, generating an average of75 patient referrals annually and increasing healthcare service outreach
- Patient Education: Conducted awareness campaigns and counseling sessions on drug abuse and scheduled drugs, improving patient understanding and safety
- Operational Efficiency: Facilitated interdepartmental collaboration to ensure compliance with SOPs, optimizing workflows and operational outcomes
- Referral Process Management: Implemented strategies to streamline patient referral processes, enhancing overall patient care and satisfaction
- Cross-functional Leadership: Coordinated efforts across departments to drive project success, ensuring alignment with organizational objectives and SOP compliance
Education
PhD in Business - Project Management Emphasis
University of The Cumberlands
Williamsburg, KY05-2027
MS in Project Management - Regulatory Affairs Concentration
Northeastern University
Boston, MA06.2020
Bachelor of Science - Pharmacy
Mumbai University
Mumbai, India05.2018
Skills
- Regulatory submissions: ANDA, eCTD, SPL, CBE-30, PAS, Annual Reports
- Labeling:21 CFR compliance, FDA guidelines, advertising and promotional review
- Project Management: Agile methodologies, risk management, integrated timelines
- Cross-functional collaboration: Quality, Technical Operations, Supply Chain
- Tools: MS Project, SmartView, ProSpec, and regulatory databases
Certification
- Project Management Professional (PMP) – PMI
- Certified Associate in Project Management (CAPM) – PMI
- FDA and PMI Certifications: Drug Review, Quality Systems, Leadership, Agile Skills
Timeline
Associate Manager, Regulatory Affairs
Granules Consumer Health Inc.
08.2023 - Current
Associate Manager, Regulatory Affairs
Granules USA, Inc.
04.2023 - 08.2023
Regulatory Affairs Associate
Granules USA, Inc.
03.2021 - 03.2023
Regulatory Affairs Associate
Spirit Pharmaceuticals LLC
07.2020 - 03.2021
Associate Project Manager
Haffkine Biopharmaceutical Co. Ltd.
05.2017 - 07.2017
Associate Manager
Saifee Hospital Pvt. Ltd.
05.2016 - 07.2016
- Project Management Professional (PMP) – PMI
- Certified Associate in Project Management (CAPM) – PMI
- FDA and PMI Certifications: Drug Review, Quality Systems, Leadership, Agile Skills
PhD in Business - Project Management Emphasis
University of The Cumberlands
MS in Project Management - Regulatory Affairs Concentration
Northeastern University
Bachelor of Science - Pharmacy
Mumbai University
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