Job Title:  Officer

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

• EC Submissions: Preparation and filing of Ethics Committee applications; follow-up for approvals and approval circulation.
• eTMF Uploading & Reviewing: Upload and review regulatory documents in the electronic Trial Master File system.
• Zonal Office Submissions: Preparation of dossiers, justification notes, and coordination with respective team.
• Central Office Submissions : Handling BE-NOC, TL, and CT applications; coordination and follow-up for approvals.
• CBN/NCB Applications: Preparation and submission of dossiers for controlled substances; follow-up for approvals.
• CTRI Registration: Preparation and submission of CTRI applications; coordination with CT Project Manager; follow-up for registration approval.
• Query Responses and tracker updation: Drafting and coordinating responses to regulatory queries; updating status trackers.
• Departmental Monthly Reports: Preparation and circulation of monthly RA activity reports.
• System/Vendor Audits: Assist during audits; prepare responses to audit observations.

EXPERIENCE

 1–4 years in CRO regulatory affairs with exposure to CDSCO submissions.

• Technical Skills:
  • • Knowledge of CDSCO, ICH-GCP, Schedule Y, CTRI requirements.
    • Proficiency in dossier preparation, eTMF systems, and regulatory trackers.
• Soft Skills:

• • • Strong communication and coordination abilities.
    • Fluency in English language.
    • Attention to detail and ability to manage multiple tasks.
    • Problem-solving and proactive approach to regulatory challenges.

EDUCATIONAL QUALIFICATION

• Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field.