Dipen G. Email & Phone Number

Regulatory Submissions and Documentation: LEarned how to prepare and submit regulatory documents, including Investigational New Drug (IND) applications, NDAs, Marketing Authorization Applications (MAA), and 510(k) submissions.Electronic Regulatory Tools and Systems: Learned how to utilize regulatory information management systems (RIMS) and electronic Common Technical Document (eCTD) software for efficient dossier compilation and submission.Clinical Trial Regulation and Oversight: Supported regulatory compliance for clinical trials by preparing Clinical Study Reports (CSRs), informed consent forms, and coordinating ethics committee submissions.Regulatory Risk Management: Learned how to identify, assess, and mitigate regulatory risks associated with product development and post-marketing activities, which would contribute to robust risk management strategies.Quality Assurance and Audits: Learned methods in assisting internal and external regulatory audits, how to facilitate corrective / preventive actions (CAPA), and quality assurance practices to ensure compliance with regulatory standards.Cross-Functional Collaboration and Communication: Learned how to work closely with cross-functional teams (R&D, clinical, quality, marketing) to align regulatory/business objectives and deciphered regulatory guidance for development.Scientific Paper Evaluation: Evaluated scientific research papers to determine suitability for publication, applying rigorous criteria to ensure the highest standards of scientific integrity and relevance.Data Management Process and Project Management: Learning effective strategies on advanced data management techniques and statistical analysis methods to ensure accurate and meaningful interpretation of clinical data, which would inevitably contribute to evidence-based recommendations for various disease states and regulatory strategies.

CMC (Chemistry, Manufacturing, and Controls) for Drug Submission: Gained expertise in developing CMC strategies and preparing documentation required for regulatory drug submissions, ensuring compliance with global standards for product quality, safety, and efficacy.Regulatory Requirements for Medical Devices: Acquired comprehensive knowledge of the regulatory framework governing medical devices in Canada, including classification, licensing processes, quality systems, and post-market surveillance under Health Canada’s guidelines.Regulatory Documentation and Submissions: Proficient in preparing and reviewing CMC documentation for drug submissions and regulatory documents for medical devices, ensuring alignment with Health Canada’s requirements and international regulatory standards.Quality Control and Assurance in Regulatory Affairs: Developed skills in ensuring that all submitted documentation meets the required quality standards for both drug and medical device regulations, supporting successful regulatory submissions.Regulatory Strategy Development: Learned how to create effective regulatory strategies for both drug and medical device submissions to accelerate approval timelines and navigate complex regulatory environments.Cross-Product Regulatory Expertise: Demonstrated ability to work across multiple product categories (pharmaceuticals and medical devices), providing regulatory guidance and support for diverse product pipelines.Regulatory Compliance Management: Learned methods of Ensuring adherence to requirements throughout the product lifecycle, from development through post-market activities, for both drugs and medical devices in the Canadian market.

Pune

Medical Writing and Documentation: Assisted in drafting standard operating procedures (SOPs) and validation reports, contributing to high-quality documentation that ensured regulatory compliance and facilitated clear communication of analytical methodologies and results.Regulatory Compliance and Quality Assurance: Executed and validated analytical test procedures for assay and dissolution using High-Performance Liquid Chromatography (HPLC), ensuring compliance with regulatory standards and improving testing precision and reliability, leading to a 100% increase in test accuracy.Analytical Expertise and Data Integrity: Conducted comprehensive analyses of various anti-diabetic oral solid dosage forms (tablets, capsules) across multiple media during product development stages, refining the selection process for bioequivalence studies.Regulatory Standards and Method Validation: Supported senior team members in validation planning and method validation in alignment with ICH/USFDA and other relevant regulatory guidelines, achieving a 70% improvement in the efficiency of the validation process.Instrumentation Management and Operational Efficiency: Managed calibration and maintenance of analytical testing instruments, including HPLC and KF-Water Content analyzers.Specimen Handling and Laboratory Optimization: Streamlined specimen processing by securing, labeling, and storing samples according to preparation protocols, leading to a 100% increase in specimen processing efficiency.Stakeholder Collaboration and Cross-Functional Communication: Collaborated effectively with cross-functional teams, including R&D, quality assurance, and regulatory affairs, to support project goals, align on regulatory requirements, and facilitate knowledge sharing, which strengthened interdepartmental communication and accelerated timelines by 25%.

Mumbai

Regulatory Compliance and Product Readiness: Streamlined pre-validation processes for three products, achieving full regulatory compliance and enhancing product readiness for market introduction.Regulatory Query Resolution and Stakeholder Engagement: Led a cross-functional team to efficiently resolve complex regulatory and market queries for marketed products, contributing to a 3% growth in organizational revenue through proactive stakeholder engagement and effective communication strategies.Project Management and Timely Delivery: Directed analytical method validation and product characterization projects, optimizing workflows.Cross-Functional Collaboration and Continuous Improvement: Collaborated with quality assurance and regulatory affairs teams to drive continuous improvement initiatives, streamline validation processes, and align with global regulatory requirements.Instrumentation Management and Quality Assurance: Managed the operation, calibration, and maintenance of key analytical instruments (HPLC, pH meters, balances, conductometers), ensuring 100% accuracy and compliance with industry standards, supporting high-quality data generation.

Mumbai, Maharashtra, India

Post Graduate Regulatory Affairs, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, Gpa: 3.63

1. Developed in-depth knowledge of regulatory requirements and submission processes for Health Canada, FDA, EMA, and other global.

Postgraduate Degree, Project Management, Gpa: 3.15

Project Planning, Execution, Control, Leadership and Communication, Risk Management

Master Of Pharmacy, Quality Assurance, First Class With Distinction

Bachelor Of Pharmacy - Bpharm, First Class