Regulatory Affairs

NAIZA PAUL

Boston, MA • 857-***-****• ****.**@************.*** •

https://www.linkedin.com/in/naiza-paul/

SUMMARY

Dedicated and results-oriented graduate student pursuing a Master's in Regulatory Affairs with a solid foundation in Biotechnology. I bring a unique blend of technical expertise and regulatory insight. Eager to leverage my academic background, analytical process, and Passion for Compliance to make meaningful contributions to the regulatory landscape in the life sciences industry

EDUCATION

Master of Science, Regulatory Affairs Expected March 2025 Northeastern University, Boston, M.A

Relevant coursework: Regulatory Strategy for Product Development, Regulatory Compliance Practice, Introduction to Safety Science, Introduction to FDA Pharma Regulations, Human Experimentation, Lean Concepts and Applications, Therapeutic Product Development, Issues in Conducting International Clinical Trials, Validating and Auditing in Clinical Trial, Optimizing clinical trial design

Master of Science in Biotechnology

Government Holkar Science College, Indore, July 2020- July 2022 Relevant coursework: Biostatistics and Bioinformatics, Immunology, Analytical Techniques, Enzyme Technology, Genomics, Proteomics, IPR and Biosafety

REGULATORY SKILLS:

Expertise in 21Code of Federal Regulation (CFR) 820,807,814, 210,211, 312,314, IND, ISO 9001, ISO 14971, ISO 13485, Good Clinical Practices (GCP), Quality Management Systems (QMS), Good Documentation Practices (GDP), Inventory Management, and Internal Audits, Chemistry Manufacturing Controls, Good Manufacturing Practices (GMP), Research and Development(R&D) TECHNICAL SKILLS: Tableau, Excel, PowerPoint, Data retrieval from Google Scholar, PubMed, Report Drafting EXPERIENCE

Intern, Dev Agro (INDIA) Chemicals and Fertilizers Ltd, Indore, India Aug 2022-Dec 2022

• Acquired exposure to diverse processes, focusing on the standardization of chemicals and quality analysis for market release

• Gained foundational skills in regulatory compliance within a brief timeframe

• Developed a keen interest in product development processes and associated rules and regulations Volunteer, Unnat Social Humanity Association, Indore, India Oct 2021-May 2022

• It’s a Non-Governmental Organization, where exposed to educate people about health awareness and the human welfare of the society

• Advocated patient-centricity, meeting healthcare needs, valued in pharmaceutical roles emphasizing satisfaction

• Monitored and evaluated project impact using data-driven approaches Part-Time, Tanishq Enterprise, Indore, India July 2020- Oct 2021

• Monitored inventory levels and optimized stock management

• Collaborated with cross-functional teams to enhance operational synergy

• Developed and maintained detailed documentation for processes and provided analytical support for decision-making processes CERTIFICATION

Food Testing

• Analytical Techniques: Proficient in chromatography, spectroscopy, and microscopy for precise food analysis

• Quality Assurance: Applied statistical methods to ensure accuracy and reliability in results

• Regulatory Compliance: Familiarity with food safety regulations and industry standards

• Instrumentation Proficiency: Expertise in HPLC, GC-MS, and PCR machines for accurate testing ACADEMIC PROJECTS

Decoded the Regulatory Framework for the t: slim X2 Pump: Mapped out the steps needed to get the t: slim X2 pump approved by regulators. This helped to understand how medical devices get the green light, what category the t: slim X2 falls under, and the specific rules it needs to follow. The process also sharpened my research, technical communication, and critical thinking skills. Prepped for a Big Pharma Merger: Wrote a letter requesting key documents to evaluate a potential merger between two drug companies. This involved figuring out what information is crucial for making informed decisions and presenting my reasoning clearly and logically. Boosted my analytical thinking, formal communication skills, and understanding of pharmaceutical M&A procedures. Mastered Drug Safety Checkpoints: Created a guide explaining the essential steps in ensuring a drug's safety before it's publicly available. This included both lab studies on animals and clinical trials with humans, covering how to analyze and report safety data. This project deepened my knowledge of drug development, safety assessments, and regulatory compliance in the pharma industry. CMC Section of regulatory filing: Explored and presented a detailed analysis of the Chemistry, Manufacturing, and Controls (CMC) section within the pharmaceutical regulatory dossiers, emphasizing its role in ensuring the quality, safety, and efficacy of drug Trastuzumab. Thoroughly Researched Trastuzumab chemistry, Active ingredients, and excipients used to make the drug, the Manufacturing Process controls, and stability studies of the drug after manufacturing throughout its shelf life.

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