Clinical Research Scientist - BE/BA(Regulatory Affairs) Techhaul360 Consulting Services

10.0 - 15.0 years

20 - 30 Lacs

hyderabad

Hybrid

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and documentation. Key Responsibilities: BE/BA & Regulatory Focus: Design and oversee Bioequivalence and Bioavailability studies across various dosage forms. Ensure strict compliance with regulatory standards (USFDA, Health Canada, WHO). Develop and review study protocols, SOPs, ICFs, and Clinical Study Reports (CSRs). Coordinate with CROs, bioanalytical labs, and internal teams for timely project execution. Interact with regulatory agencies and provide scientific responses to queries/deficiencies. Monitor regulatory trends and update internal SOPs and processes accordingly. Clinical Study Operations: Serve as Sponsors representative in assigned clinical studies, ensuring ethical and procedural compliance. Oversee dosing of study subjects , subject safety follow-ups , and ensure adherence to ICH-GCP. Review and compile raw clinical data, ensure proper monitoring and quality control (QC) . Prepare clinical updates , confinement reports , clinical summary reports , and ensure accuracy of clinical documentation. Review and finalize study documents, then hand over to QA for further processing. Support in EC submissions of protocols and related documentation. Manage study initiation , execution , archival , and retrieval of clinical records. Address and close QA/Sponsor queries and observations. Required Skills & Competencies: Deep understanding of ICH-GCP and regulatory guidelines (USFDA, CDSCO, Health Canada, WHO). Strong background in pharmacokinetics, clinical study design, and regulatory documentation. Ability to perform both strategic planning and hands-on clinical trial execution. Proficiency in clinical data handling, document management, and compliance tracking. Preferred Candidate Profile: Strong interpersonal skills and leadership qualities. Exposure to complex generics and/or challenging dosage forms is an advantage. Educational Qualifications: B.Pharm , M.Pharm , and Ph.D. in Pharmaceutical Sciences, Clinical Research, or a related field

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