Clinical Research Scientist - BE/BA(Regulatory Affairs)

Job Summary:

Clinical Research Scientist

Sponsors Representative

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