Headline

PharmD | Rph | Clinical Trials Regulatory Affairs Professional | India & Malaysia (CDSCO & NPRA)

About

I am a PharmD graduate with 4+ years of experience in Clinical Research and Regulatory Affairs at CROs in India. I started my career as a Clinical Research Associate at Nextvel Consulting LLP, where I worked directly at clinical trial sites — handling feasibility assessments, monitoring visits, SDV. This gave me a solid, practical understanding of how trials run on the ground, which made me a more effective Regulatory Affairs professional. 🇮🇳 India (CDSCO) — I handle CT-04 (CTA), CT-10 (MLA), and CT-16 (TLA) applications, post-approval submissions (Protocol Amendments, IMPD, ICF, IB), Ethics Committee filings, and safety reporting including SAE reports, SUSAR Line Listings, and DSURs — ensuring full compliance with ICH-GCP and NDCTR 2019. 🇲🇾 Malaysia (NPRA) — I prepare and manage Clinical Trial Applications and Import License submissions to the National Pharmaceutical Regulatory Agency, coordinate with local Malaysian agents and investigators, resolve NPRA queries, and ensure compliance with ICH-GCP and Malaysia’s Control of Drugs and Cosmetics Regulations (CDCR). I do not just file documents. I help trials move forward.

Location

Bengaluru

Work experience

Regulatory Affairs Assistant (Clinical Trials) at PSI CRO AG, Apr 2024 - Present · 2 yrs 4 mos, Bengaluru, Karnataka, India, As a Regulatory Affairs Assistant, I possess extensive experience in drafting and reviewing regulatory documentation, including Clinical Trial Applications (CTAs), Manufacturing License Applications (MLAs), and Test License Applications (TLAs). I ensure that all documents are accurate, complete, and comply with CDSCO regulations and standards throughout the preparation and submission process. Key competencies include: • Compliance and Quality Control: I ensure that all documentation aligns with CDSCO guidelines by applying quality control measures to guarantee consistency and accuracy, thereby supporting successful approval processes. • Collaboration: I work closely with both internal teams and external stakeholders to resolve queries, provide clarifications, and ensure smooth regulatory review processes. • Issue Resolution: I identify and resolve discrepancies in regulatory submissions to guarantee timely and accurate filings. • Document Management: I am proficient in managing document systems for versioning, organizing, and tracking regulatory materials throughout the submission lifecycle. • Communication with CDSCO: I act as the liaison for CDSCO communications, providing necessary clarifications and supporting the timely review and approval of applications. • Clinical Trial Insurance Compliance: I am well-versed in regulatory frameworks for clinical trial insurance, including indemnity and compensation requirements for trial-related injuries, and oversee insurance policy renewals to ensure continuous CDSCO compliance. • Green light documents: Review documents to green light IP releases to sites. • Additional Regulatory Affairs Support: I handle any other regulatory tasks as assigned, ensuring comprehensive and timely support for all regulatory affairs needs. This approach succinctly outlines my key responsibilities and skills while emphasizing my expertise in managing regulatory processes and compliance with CDSCO standards.

Regulatory Affairs Associate II at Nextvel Consulting LLP, Jul 2023 - Mar 2024 · 9 mos, Bengaluru, Karnataka, India, *Proficient in drafting and compiling regulatory submissions for drugs and medical devices in accordance with Indian CDSCO requirements. *Demonstrated skill in preparing comprehensive documents such as Investigational New Drug and Medical Device Registration dossiers. *Skilled in drafting and reviewing documentation such as Clinical Trial Applications (CTAs), Manufacturing License Applications (MLAs), and Test License Applications (TLAs), ensuring accuracy and completeness. *Ensured compliance with CDSCO regulations and standards throughout the preparation and submission of regulatory documents. *Implemented quality control measures to verify the accuracy, consistency, and compliance of documentation with CDSCO requirements, facilitating successful approval processes. *Collaborated with internal and external stakeholders to address queries and provide clarifications during CDSCO review processes. *Skilled in identifying and resolving issues or discrepancies in regulatory documentation, ensuring timely and successful submissions to CDSCO. *Proficiency in document management systems for organizing, versioning, and tracking regulatory documents throughout the submission lifecycle. *Experience maintaining regulatory archives and ensuring documentation is ready for regulatory inspections by CDSCO authorities. *Facilitated communication with CDSCO officials to address queries, provide clarifications, and ensure timely review and approval of applications. *Experienced in navigating regulatory frameworks pertaining to clinical trial insurance mandates, including understanding requirements for indemnity and compensation in case of trial-related injuries or adverse events. *Capable of overseeing the timely renewal and documentation of insurance policies throughout the duration of clinical trials, mitigating risks and ensuring continuous compliance with CDSCO regulations. *Handle any other regulatory affairs related tasks assigned by the management from time to time

Clinical Research Associate I at Nextvel Consulting LLP, May 2022 - Apr 2023 · 1 yr, Bengaluru, Karnataka, India, • Work in close coordination with Senior CRA’s • Prepare protocols for clinical studies and handle trial responsibilities • Maintain electronic tracking logs and documentation. • Conduct Study Feasibility • Perform Site Selection Visits • Perform Site Monitoring Visits-On-Site and Remote • Perform Site Close -out Visits • Ensure compliance with ICH GCP, SOPs, and applicable regulations, identify opportunities to reduce protocol deviations • Safety Reporting to Regulatory, Sponsors, and IRB/EC. • Identify site issues and initiates correction plans based on monitoring reports. • Handle Source Data Verification, and data query resolution within stipulated timelines • Validate Clinical Trial Databases and configure e-CRFs • Identify issues and suggest solutions after discussion with management CONFIDENTIAL • Face internal/sponsor and vendor audits and implement CAPA in discussion with management and QA • Train the sites on the protocol requirements, make all attempts to reduce Protocol Deviations • Contract negotiation finalization of Site Budgets • Keep track of patient recruitment, ensure timely completion of enrolment targets and site budgets • Ensure Good Documentation Practices and Data Integrity • Promptly report any scientific misconduct to management, when identified

Student Intern at St. Philomena’s Hospital, Apr 2021 - Apr 2022 · 1 yr 1 mo, Bangalore Urban, Karnataka, India

Education

Doctor of Pharmacy - PharmD, Rajiv Gandhi University of Health Sciences

Doctor of Pharmacy - PharmD, Pharmacy, Al ameen pharmacy college