Regulatory Affairs Specialist Regulatory Strategy & Compliance

Shruti Amol Joshi

************@*****.*** 617-***-**** USA LinkedIn Profile

Experience

RA Intern Apr 2025 – Jun 2025

Neutron Therapeutics, Boston

• Supported regulatory strategy development for the NuBeam Suite, an innovative therapeutic platform with device– drug combination considerations, ensuring alignment with FDA expectations for advanced medical technologies.

• Conducted regulatory research on FDA guidance, classifications, and precedents related to novel therapeutic devices and combination products, contributing to pathway planning for a future Class III submission.

• Assisted in compiling documentation for pre-IND and early regulatory interaction packages, ensuring materials met internal standards and FDA requirements.

• Performed regulatory assessments through competitive research and literature review to support risk evaluation and regulatory positioning.

• Participated in cross-functional team discussions with clinical, preclinical, and engineering groups to understand regulatory impacts across the product lifecycle.

• Contributed to regulatory document organization and tracking, supporting compliant documentation practices. Regulatory Affairs (QA) Intern Jul 2024 – Jan 2025 Aurobindo Pharma and Aurolife Pharma Unit II, North Carolina.

• Assisted senior RA staff with regulatory submission preparation, including ANDA modules and supporting documentation, ensuring accuracy, completeness, and alignment with FDA and ICH guidelines.

• Gained hands-on experience in regulatory database management, document control, and maintenance of RA records in accordance with internal procedures.

• Conducted regulatory research and risk-based assessments related to generic drug approvals, timelines, and submission requirements.

• Participated in internal regulatory strategy discussions and observed cross-functional decision-making relevant to product lifecycle management.

• Supported the preparation of responses to regulatory inquiries, coordinating information under supervision from subject matter experts.

Regulatory Affairs Associate Sept 2021 – Aug 2023

Allied Packaging Technologies, India.

• Managed regulatory compliance activities for packaging materials and machinery, ensuring adherence to FDA, USDA, ISO, and international packaging regulations.

• Maintained regulatory documentation and databases for blister packing machines and change parts, supporting multi-market product registrations and lifecycle management.

• Conducted regulatory assessments for product and process changes, evaluating impact and communicating required actions to internal stakeholders.

• Collaborated with cross-functional teams including R&D, Quality, Operations, and Manufacturing to ensure regulatory requirements were met throughout the product lifecycle.

• Prepared and submitted regulatory filings with a 95% first-time approval rate, demonstrating accuracy, effective documentation, and strong understanding of regulatory requirements.

• Performed regulatory impact evaluations and risk assessments for new product development and proposed changes, recommending mitigation strategies when needed.

QA/ QC Intern Jun 2021 - Aug 2021

Athena Drug Delivery Solutions Pvt Ltd, India

• Supported QA activities including batch record review, SOP compliance checks, deviation support, and maintenance of documentation in line with GDP and regulatory standards.

• Assisted in QC testing and validation processes (HPLC, RAMAN, inspection methods), contributing to compliance with FDA, ISO, and internal quality standards.

• Participated in cross-functional QA–QC communication, gaining understanding of how regulatory and quality requirements guide product development and release.

• Maintained documentation, logs, and controlled records following company policies and regulatory requirements. Education

Master of Science in Regulatory Affairs Sep 2023 - Jun 2025 Northeastern University, USA 3.91 GPA

Relevant Coursework - Pharmaceutical Regulation, Advanced Regulatory Writing, Strategic Planning and Project Management, Therapeutic Product Development, Medical Device Regulation, Risk Management: Compliance and Processes, Product Development and Process Validation, Global Impact of Electronic Common Technical Document (eCTD) Submissions. Bachelor’s Pharmacy Aug 2019 - May 2022

Mumbai University, India 3.2 GPA

Relevant Coursework - Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Analysis, Pharmaceutical Microbiology, Medicinal Chemistry, Pharmacotherapy, Regulatory Affairs, Pharmaceutical Quality Assurance and Control. Diploma in Pharmacy

Dr. D. Y. Patil Institute of Pharmacy, Pune 3.0 GPA Aug 2017 – May 2019 Relevant Coursework - Pharmacognosy, Human Anatomy and Physiology, Biochemistry, Hospital and Clinical Pharmacy, Pharmaceutical Jurisprudence, Drug Store and Business Management, Health Education and Community Pharmacy. Skills

• Regulatory expertise: US FDA Class III medical devices, combination products, Regulatory strategy development (post-market lifecycle), Regulatory assessments for product and process changes, Risk assessment & mitigation planning, PMA supplements, annual reports, and post-approval submissions.

• 21 CFR Part 820, 21 CFR Part 4, 21 CFR Parts 210/211, ISO 13485, ISO 14971 (risk management), ISO 90001, eCTD structure & regulatory documentation standards, FDA guidance interpretation & regulatory intelligence, GMP/GDP/GCP compliance and internal communication cascades, Regulatory documentation management & database maintenance, Change control, compliance audits, and quality system alignment, Cross-functional regulatory support (QA, Clinical, R&D, Operations, Supply Chain)

• Proficient in drug@FDA, DailyMed, and MS Office Suite (Excel, Word, PowerPoint, Outlook).

• Strong analytical, problem-solving, and project management abilities; excels in multitasking and strategic planning.

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