Specialist, Regulatory & Site Activation

Overview

Subject matter expert and local point of contact for regulatory submissions support, site activation, and site maintenance for awarded projects.

What you'll do

• Support end-to-end site start-up from site identification to activation and maintenance.
• Serve as the primary country-level point of contact for regulatory and site activation activities.
• Customize country-specific patient information, informed consent, labels, and local regulatory documents to meet ICH GCP and country requirements.
• Review and advise on country timelines for assigned studies.
• Collect, first-review, and provide required study-specific site essential/ regulatory documents per SOPs and plans, and track them by site/country.
• Identify country/site risks and create mitigation strategies; communicate status, risks, and action plans to stakeholders.
• Maintain regulatory intelligence by updating changes in regulations and support interpretations for assigned countries.

What you'll need

• Minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or related science.
• Minimum two years of experience in clinical research, preferably in site activation and/or regulatory-related functions.
• Preferred minimum of one year of previous experience in the pharmaceutical/CRO industry.
• Good knowledge of ICH GCP, clinical research conduct guidance, and country regulations.
• Multilingualism preferred, including fluent local language and working knowledge of English.
• Proficiency in MS Office applications including Word, Excel, and PowerPoint.

Details

• Location: Virtual India.