Self driven professional with a strong background in regulatory submissions, clinical research, medical writing, and project management. I hold a Post-Graduate Certificate in Regulatory Affairs and Project Management from Conestoga College, a Master’s in Quality Assurance, and certifications in CMC for Drug Submission, Six Sigma in Healthcare, and Medical Devices Regulation. Recognized by the National Institute of Pharmaceutical Education and Research (NIPER), I bring a deep understanding of global regulatory frameworks, compliance strategies, and quality systems.In my roles as a Research Associate at IRA Consultancy and MacLeod’s Pharmaceuticals Ltd., I managed complex regulatory submissions, conducted clinical trial monitoring, and led cross-functional teams to achieve key objectives. I have driven projects in adverse event reporting, developed pre-clinical study protocols, and enhanced product readiness by streamlining validation processes. My expertise includes developing high-quality scientific communications, regulatory compliance, and risk mitigation strategies, leading to significant increases in product submission rates.I am passionate about advancing patient care through innovative research and patient-centered solutions. With proven skills in stakeholder engagement, data quality assurance, and regulatory intelligence, I am dedicated to contributing to impactful healthcare solutions. KEY COMPETENCIESRegulatory Strategy DevelopmentClinical Trial Monitoring (CTM)Medical Writing (MW)Adverse Event Reporting (AER)Cross-Functional Collaboration (CFC)Risk Management Strategies (RMS)Good Clinical Practice (GCP)Protocol DevelopmentPatient Recruitment StrategiesRegulatory Submissions (eCTD)Data Integrity AssurancePharmacovigilance (PV)Safety Signal DetectionQuality Assurance (QA)Standard Operating Procedures (SOPs)Clinical Study Reports (CSRs)Compliance AuditingRegulatory Intelligence (RI)Ethics Committee SubmissionsRoot Cause Analysis (RCA)Project Management (PM)Lifecycle Management (LCM)Labeling ComplianceStakeholder EngagementPost-Market Surveillance (PMS)Clinical Development Plans (CDP)Real-World Evidence (RWE)Benefit-Risk Assessment (BRA)Change Control Management (CCM)Safety Database Management (e.g., Oracle Argus, Veeva Vault)Electronic Regulatory Submissions (eSub)Risk Evaluation and Mitigation Strategies (REMS)Data Management and AnalysisVendor Management and OversightSafety Report WritingRegulatory Affairs and Compliance TrainingLiterature Review and SynthesisContact:dpeengaikar@gmail.com
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Regulatory Affairs And Project Management Post-Grad CertificationConestoga College Post-Graduate Training Aug 2022 - Apr 2024Regulatory 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.
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Cmc For Drug Submission And Medical Devices Regulation CertificationConestoga College Post-Graduate Training Aug 2022 - Apr 2024CMC (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.
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Sr. Research Lab AssociateIra Consultancy And Research Organisation Nov 2019 - Dec 2022PuneMedical 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%. -
Research AssociateMacleods Pharma. Ltd. (R & D Centre) Aug 2017 - Oct 2019MumbaiRegulatory 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.
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Research InternAlkem Laboratories Ltd. Jun 2016 - Jan 2017Mumbai, Maharashtra, India
Dipen G. Education Details
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Gpa: 3.63 -
Gpa: 3.15
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First Class With Distinction -
First Class
Frequently Asked Questions about Dipen G.
What is Dipen G.'s role at the current company?
Dipen G.'s current role is Sr. Research Associate at IRA Consultancy Inc. | Regulatory Affairs Enthusiast | CMC and Quality | Data and Project Management | eCTD Authoring and Compliance | FDA / EMA / Health Canada Guidance | Medical Writing.
What schools did Dipen G. attend?
Dipen G. attended Conestoga College, Conestoga College, Kavayitri Bahinabai Chaudhari North Maharashtra University (Kbcnmu), Jalgaon, Savitribai Phule Pune University.
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