Regulatory Affairs & Compliance Specialist Resume

VENKATA AKHIL KATTA

Boston, MA +1-617-***-**** *****************@*****.*** linkedin.com/in/venkata-akhil-katta EXPERIENCE

Regulatory Affairs Specialist, Community Dreams Foundation, Florida 06/2025 – Present

• Ensured compliance with FDA 21 CFR Part 820, ISO 13485, and QMS requirements through regulatory analysis, audit support, and compliance reporting.

• Collaborated with cross-functional teams (Quality, Operations, Engineering) to implement CAPA tracking systems and support manufacturing process improvements.

• Analyzed quality and compliance data using statistical tools (Excel, Tableau) to generate performance reports and identify process optimization opportunities.

• Maintained regulatory documentation databases and coordinated with manufacturing teams to align quality standards with production workflows.

• Supported EHS&S compliance initiatives and regulatory audits, ensuring adherence to safety protocols and procedures. Regulatory Affairs Intern, Neutron Therapeutics LLC, Danvers, MA 01/2025 – 06/2025

• Developed a De Novo classification strategy for Class II medical devices through a comprehensive analysis of FDA pathways, CDRH databases, and CFR regulations (Parts 820, 860, 892).

• Coordinated with cross-functional teams (Engineering, Quality, Clinical) to align technical documentation and regulatory submissions for FDA and EU markets.

• Prepared SOPs, submission roadmaps, and quality documentation, ensuring compliance with 21 CFR Part 820, ISO 14971, and ISO 13485.

• Compiled and validated regulatory data from FDA sources to support device registration and manufacturing data management. Medical Scribe, AQuity Solutions, Visakhapatnam, India 10/2022 – 04/2023

• Expertly utilized Epic EHR for efficient patient data management and SOAP note design.

• Collaborated with physicians to ensure accurate, timely documentation, improving patient care.

• Strong knowledge of medical terminology, pharmacology, and specialties; skilled at prioritizing tasks and working independently.

PROJECTS

Manufacturing Process Improvement & Quality Analysis Initiative, Northeastern University, Boston, MA 09/2024 – 12/2024

• Led a team of 8 in analyzing pharmaceutical manufacturing workflows to identify process improvement opportunities using data-driven methodologies.

• Developed process documentation and SOPs for quality control procedures in pharmaceutical manufacturing settings.

• Applied root cause analysis and statistical tools to address production bottlenecks and optimize workflow efficiency.

• Created Excel-based dashboards to track quality metrics and manufacturing KPIs for continuous improvement initiatives. Drug Repurposing and Research, Northeastern University, Boston, MA 06/2024 – 08/2024

• Conducted literature reviews to identify existing drugs for repurposing, utilizing databases and academic journals.

• Demonstrated strong project management skills in research, including prioritization, communication, and fostering innovation.

Regulatory Approval Processes of Covid-19 Vaccines in India, SVCP, India 02/2022 – 05/2022

• Analyzed and documented vaccine development stages, including regulatory approval for COVAXIN and COVISHIELD, demonstrating understanding of complex regulatory landscapes.

• Developed expertise in Emergency Use Authorization (EUA) policies and the regulatory frameworks enabling accelerated access to SARS-CoV-2 vaccines and therapeutics.

• Acquired knowledge of marketing authorization and quality assessment protocols to ensure vaccine development and distribution compliance.

SKILLS

Regulatory Affairs: Regulatory Compliance, FDA Regulations and Strategy, Medical Device Reports (MDR), ISO, QMS, Quality Assurance, GMP, GCP, GLP, 510(k) Submissions, IND, ANDA, NDA, CDRH, CMC, Adverse Drug Reactions (ADR), Drug development, Pharmacovigilance, Packaging, Labelling and Documentation, eTMF, IRB Submissions, CTMS, Regulatory Strategy, Risk Management, OUS Regulations, Product Life-cycle Management. Manufacturing & Operations: Manufacturing Process Improvement, Cross-functional Team Collaboration, Workflow Monitoring & Optimization, CAPA Management, Root Cause Analysis, Equipment Validation Support, EHS&S Compliance, Production Planning Support, Budget Monitoring, Process Documentation & SOPs. Virtual Scribe: Electronic Health Records (EHR), Medical Documentation, Medical Terminology, Patient Charting, Typing Speed and Accuracy (60 wpm), HIPAA Compliance, Transcription Skills, Data Entry, Attention to Detail, and Communication Skills. Pharmacy: Pharmaceutical Chemistry, Organic Chemistry, Microbiology, Human Anatomy and Physiology, Industrial Pharmacy, Physical Pharmacy, Cosmetic Sciences, Clinical Pharmacy, Environmental Sciences, Pharmacology, Novel Drug Delivery System, Inorganic Chemistry, Pharmacovigilance, and Human Ethics. Regulatory Affairs Technology: RIMS (Veeva RIM), EDMS (Lucid Chart, SharePoint, Google Drive, GraphPad), Data Analysis, and Visualization Tools (Excel, Tableau, Google Charts). Laboratory Techniques: Chromatographic techniques (HPLC, TLC, Column, Gas), Spectroscopy (UV-Visible, IR), Disintegration, Dissolution, and Friability testing, Formulation, Compounding, and Dispensing, Limit tests for Impurities (chloride, sulphate, iron, heavy metals), Qualitative and Quantitative Chemical Analysis, Microbiological Techniques (sterility, culture media preparation, microbial limit tests).

CERTIFICATIONS

ORAQ Regulatory Affairs Training Program (Duke University); CPR/AED Certification, Certified Personal Trainer (CPT), Drug Discovery, The Science of Stem Cells, AI For Everyone, Biohacking Your Brain’s Health, Mind Control: Managing Your Mental Health During COVID-19 (Coursera)

LEADERSHIP

Team Lead, Drug Repurposing Research Project, Northeastern University, Boston 06/2024 – 08/2024

• Led and coordinated a team of 8 researchers in exploring therapeutic applications of existing pharmaceutical compounds.

• Demonstrated project management, prioritization, and team motivation skills without direct supervisory authority. Captain, Cricket, IML (Northeastern University, Boston) & PPL (Shri Vishnu College of Pharmacy) 10/2021 – 06/2025

• Captained cricket teams to victory in inter-university matches during undergraduate and postgraduate studies.

• Developed ability to set objectives, motivate team members, and adapt strategies based on changing conditions. VOLUNTEER EXPERIENCE

Volunteer, Community Servings (Boston) 01/2024 – Present

• Support weekly food preparation and packaging operations for chronically ill and homeless individuals across Massachusetts.

• Demonstrate commitment to community health and operational efficiency in a mission-driven environment. NSS (National Service Scheme), India 07/2019 – 08/2022

• Volunteered in community outreach programs, health camps, cleanliness drives, and awareness campaigns. EDUCATION

Northeastern University, Boston, MA 09/2023 – 06/2025 Master of Science in Regulatory Affairs GPA – 3.8/4 Relevant Coursework: FDA – Biopharmaceutical & Medical Device Regulation, Regulatory Strategy, and Compliance, Strategic Planning and Project Management for Regulatory Affairs, Biotechnology - Methodological Issues, CMC Regulations and Methods, Legal Issues in International Food, Drug, and Medical Device Regulation, Pharmaceutical, and Medical Device Law. Shri Vishnu College of Pharmacy (SVCP), Bhimavaram, India 09/2018 – 07/2022 Bachelor of Pharmacy Awarded for qualifying in GPAT 2022 and NIPER 2022 GPA – 3.4/4 Relevant Coursework: Industrial and Physical Pharmacy, Cosmetic Sciences, Pharmaceutical Regulatory Science, Pharmacology, Pharmaceutical Analysis, and Pharmaceutical Chemistry.

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