Dr. Neha Singh

- DR.NEHA SINGH - Regulatory Specialist Pune-411028 https://www.linkedin.com/in/drneha-singh-1b2418bb SUMMARY Experienced Regulatory Affairs Officer with a total of 13 years, including almost 6 years in the Medical Device sector, focusing on regulatory compliance and process optimization. Enhanced product development processes to align with international regulatory requirements for the EU market. Diligently managed regulatory records and submissions. Well-versed in recent developments in regulatory and clinical affairs. Published 8 research articles in leading scientific journals, showcasing expertise in scientific communication. EDUCATION PROFESSIONAL EXPERIENCE Guru Gobind Singh Indraprastha University Regulatory Specialist Ph.D- Chemistry 2016 Tata Elxsi 2021- present BarkatullahUniversity M.Sc. Biotechnology 2004 – 2006 SKILLS EUMDR 2017/745 Technical documentation Product lifecycle management Post-market surveillance Product labeling and instructions for use Regulatory compliance and oversight 21 CFR 820 US FDA regulations SaMD, SaaS CE marking (EUMDD and EUMDR) Unique device identification (UDI) Veeva Vault management Windchill documentation ISO 13485:2016 (QMS) IEC 62304 ISO 14971 risk management High-performance liquid chromatography (HPLC) Gas chromatography (GC) High-performance thin-layer chromatography (HPTLC) Good manufacturing practices (GMP) Good clinical practices (GCP) Microsoft Office Suite proficiency Strong organizational and time-management skills Exceptional communication and interpersonal skills Ability to work independently and as part of a team CERTIFICATIONS Verified International Education Qualification https://www.youracclaim.com/badges/dc8ba839-95d14a28-b276-70ff0a428079?source=linked_in_profile Executed regulatory activities to ensure compliance with regulatory agency regulations and quality systems. Drafting, reviewing, and submission of regulatory filings, like technical files (STED), GSPR checklists, DoC, and regulatory plans, per EUMDR 2017/745. Managed interactions with EU notified bodies and other agencies regarding submissions and clarifications. Reviewed design control documentation according to US, EU, and global regulatory standards. Assessed product changes for regulatory compliance impacting US and CE Mark requirements. Coordinated with global teams to validate RIMS/UDI data and supported notified body audits. Maintaining Product Life Cycle Management. Conducted research on new regulations to keep up to date on changes in the industry. Investigated complaints about potential noncompliance issues raised by customers or employees. Provided training and guidance to personnel regarding regulatory requirements. Attended all mandatory training sessions and keeping a record of it. Represented the company at hearings, conferences, and meetings with global and local regulators. Identifying areas where existing policies need improvement or updating due to changing legislation or regulation. Worked closely with other departments to ensure that proposed business activities comply with applicable laws and regulations. Maintaining the RA database on RIMS. Ensuring the timely completion of assigned corrective actions and quality issues. Research Scientist Central Drugs Standard Control Organization (CDSCO), DGHS,MOHFW|- Undertaking technical assessment for Medical Devices as per the Medical Device Rules of 2017. Providing technical assistance toward the identification and regulation of medical devices. Reviewing wholesale licenses for medical devices from stakeholders and renewing the existing license when required. Strong knowledge and experience of EU MDR 2017/745, EU MDD 93/42/EEC, and standards like ISO 13485:2016, ISO 14971, etc. Review of applications for the issuance of import, manufacturing, and test licenses on the SUGAM portal. Screening and reviewing of CTD (Common Technical Document) dossiers, test reports, stability data, etc. pertaining to registration, import license, and approval of manufacturing license as per the Drugs and Cosmetics Act and Rules, 1945 thereunder. Review of non-clinical and clinical data, serious adverse events, PMS data, clinical trial protocol, case report form (CRF), and informed consent documents for regulatory compliance. Resolving queries and clarifications of medical device industries. Pharmacopoeial Associate Indian Pharmacopoeia Commission | 2012 - 2019 Conducting Routine analysis of raw materials, intermediates, finished products, API by using calibrated analytical instruments such as HPLC, GC, HPTLC, AAS, IR, UV-Vis, NMR and conventional methods. Analysis and documentation related to validations, stability study and standard preparation. Observing and complying with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) Compiling technical reports and SOP's. Analysis of stability samples, working standard qualification, maintenance of working standards and certified reference standards like IPRS. Organize project meeting with experts and presentation of interim results in departmental meetings and other related documentation. Deal with stakeholders' queries and efficiently solve them. Drafting of Drug monographs and general chapters in IP. Harmonizing the current monographs in IP with European Pharmacopoeia, United States Pharmacopoeia, British Pharmacopoeia and Japanese Pharmacopoeia. Completing all documentation work for release of materials including status labels and COA. Operate and perform routine maintenance and calibration of analytical instruments like HPLC, pH meter, Auto titrator, UV, IR, and Analytical balance, while adhering to protocols and safety guidelines. Maintaining accurate, real-time records of all lab activities. Liaising with other members of the quality department to investigate non-conformances. Accomplishments Extra Mile Awards for three consecutive years: 2022, 2023, and 2024 Customer appreciation emails Trainings Quantification of Hepatitis B Surface Antigen in Samples Collected from Blood Banks, Six Months Training, National Institute of Biologicals, Noida Hobbies Playing Table Tennis