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Site Readiness and Regulatory Specialist

2 weeks ago

Mumbai, Maharashtra, India Lifelancer Full time
Company Overview
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

Job Description
As a Site Readiness and Reg Specialist II, you will develop awareness of regulatory legislation, guidance, and practice in assigned regions and countries with support from senior staff. You will complete activities for clinical trial applications according to the European Clinical Trials Regulation No 536 2014 in the Clinical Trials Information System (CTIS) under supervision and close collaboration with colleagues.

Responsibilities
• Completes Part I application information in CTIS
• Accurately uploads all Part I and Part II documents to CTIS
• Initiates payment process for Part I and/or Part II submission fees and seeks approval from Global Regulatory Submissions Lead (GRSL)
• Monitors CTIS and promptly informs GRSL of all received alerts in CTIS
• Ensures timely tracking of all submissions and approvals in applicable tracking tools
• Uploads final submitted package to Trial Master File and performs functional reviews as applicable
• Performs review of final submission documents as applicable and specifically performs QC of Part II applications as delegated
• Submits application notifications in CTIS upon permission of GRSL
• Ensures high-quality documents are uploaded and filed and systems are updated on an ongoing and timely basis, making Fortrea ready for audit at any time

Required Skills and Qualifications
• Strong knowledge of regulatory legislation, guidance, and practice in assigned regions and countries
• Excellent communication and organizational skills
• Ability to work effectively in a team environment
• Proficiency in using CTIS and other relevant software applications

Benefits
Lifelancer offers a dynamic and supportive work environment that promotes growth and development. Our talented team shares our passion for overcoming barriers in clinical trials and revolutionizing the development process.