Abrar Admin

DRK Research Solutions

Roles and Responsibilities<ul><li>Prepare, review, and submit regulatory documents, including Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, and protocol amendments.</li><li>Ensure compliance with ICH-GCP, FDA, EMA, WHO, and local regulatory guidelines for clinical trials.</li><li>Maintain up-to-date knowledge of regulatory requirements and communicate changes in the regulatory requirements to internal teams.</li><li>Act as the primary point of contact with regulatory agencies, central/national ethics committees, and institutional review boards (IRBs).</li><li>Coordinate responses to regulatory queries and deficiencies to ensure timely approvals.</li><li>Maintain regulatory files, study-specific documents, and trial master files (TMF) in compliance with SOPs and GCP guidelines for regulatory correspondence.</li><li>Assist in the development, review, and revision of regulatory Standard Operating Procedures (SOPs).</li><li>Ensure that all clinical trial approvals, amendments, and safety reports are accurately documented and archived.</li><li>Support regulatory submissions related to Investigational Medicinal Products (IMP), including labeling, import/export licenses, and distribution approvals.</li><li>Monitor and submit Adverse Event listings and Serious Adverse Event (SAE) reports to regulatory authorities as per reporting timelines.</li><li>Participate in internal audits, inspections, and regulatory readiness programs.</li><li>Work closely with clinical operations, quality assurance, data management, and sponsors to ensure regulatory compliance throughout the trial lifecycle.</li><li>Support business development teams by providing regulatory insights for proposals and feasibility studies.</li></ul>Requisites for the Role<ul><li>High Analytical Ability</li><li>Business Intelligence</li><li>Commercial Awareness</li><li>Excellent Project Management</li><li>Strong Communication</li><li>Resilience</li></ul>Education: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Life Sciences, or in a related field.Experience: 02&ndash;03 years of experience in Regulatory Affairs within a Pharmaceutical Company, or a Clinical Research Organization.Job Type: Full-timePay: From Rs65,000.00 per monthWork Location: In person

Senior Regulatory Officer

Roles and Responsibilities<ul><li>Assist in receipt of material in warehouse in accordance with GDP/GMP standards.</li><li>Support in labelling and packaging activities of drugs and ancillary supplies for dispatch.</li><li>Stock management, including batch traceability, expiry tracking, cycle counting and reconciliation of physical stock.</li><li>Assist in storage of temperature-sensitive products under required conditions (2&ndash;8&deg;C, 15&deg;C-25&deg;C etc.).</li><li>Monitor and validate temperature data from data loggers and real-time monitoring systems.</li><li>Support investigations of temperature excursions.</li><li>Assist in planning and execution of cold chain shipments for outbound distribution.</li><li>Liaise with courier partners for timely delivery of outbound shipments.</li><li>Communicate with supplier representatives for shipment planning and inventory updates.</li><li>Support return handling processes.</li><li>Ensure proper documentation of all warehouse and logistics activities including shipping documents, temperature logs etc.</li><li>Assist in preparing documents for audits and inspections.</li><li>Assist the warehouse manager in managing timelines and deliverables across multiple clinical trial projects.</li></ul>Requisites for the Roles<ul><li>Familiarity with GDP/GMP</li><li>Good organizational, multitasking, and communication skills.</li><li>Proficiency in MS Office Suite (Excel, Word, Outlook).</li><li>Ability to work in a fast-paced, regulated environment with attention to detail.</li></ul>Education: Bachelor&rsquo;s degree in Supply Chain, or Related field.Experience: 1-2 years of experience in pharmaceutical warehousing, logistics, preferably in cold chain management.Job Type: Full-timePay: From Rs50,000.00 per monthWork Location: In person

Supply Chain Officer

Roles and Responsibilities<ul><li>Provide support for clinical trial activities under direct supervision.</li><li>Assist in organizing and maintaining trial-related files and regulatory binders.</li><li>Support CRC-I/CRC-II in coordinating patient visits and follow-ups.</li><li>Perform data entry into CRFs/EDC systems as instructed.</li><li>Prepare visit reminders and follow-up calls under guidance.</li><li>Maintain inventory of study-related supplies and kits.</li><li>Observe and learn to assist with informed consent and participant communication.</li><li>Attend training sessions and assist with basic documentation during site initiation and monitoring visits.</li></ul>Requisites for the Role<ul><li>High proficiency with full Microsoft applications</li><li>Strong spoken and written communication skills to include grammatical/technical writing</li><li>Good Report Writing Skills</li></ul>Education: Only Bachelors or Masters in Pharm DExperience: Minimum 1 to 3 years of relevant experience.Job Type: Full-timePay: From Rs65,000.00 per monthWork Location: In person

Clinical Research Associate

Roles and Responsibilities<ul><li>Provide support for clinical trial activities under direct supervision.</li><li>Assist in organizing and maintaining trial-related files and regulatory binders.</li><li>Support CRC-I/CRC-II in coordinating patient visits and follow-ups.</li><li>Perform data entry into CRFs/EDC systems as instructed.</li><li>Prepare visit reminders and follow-up calls under guidance.</li><li>Maintain inventory of study-related supplies and kits.</li><li>Observe and learn to assist with informed consent and participant communication.</li><li>Attend training sessions and assist with basic documentation during site initiation and monitoring visits.</li></ul>Requisites for the Role<ul><li>High proficiency with full Microsoft applications</li><li>Strong spoken and written communication skills to include grammatical/technical writing</li><li>Good Report Writing Skills</li></ul>Education: Bachelors or Masters in Only Pharm DExperience: Minimum 1 to 3 years of relevant experience.Job Type: Full-timePay: From Rs70,000.00 per monthWork Location: In person

Clinical Research Coordinator

Join DRK Research Solutions and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

DRK Research Solutions

About Company

Senior Regulatory Officer

Supply Chain Officer

Clinical Research Associate

Clinical Research Coordinator