Title : Clinical Trial Regulatory Submission SME
Location : India (Remote)
Contract Duration : 6–12 months
Hours: Up to 150 hours/month
Working Hours : EU/UK-aligned working hours may be required
Start Date : ASAP

Company Overview:

Apsida Life Science is partnering with a leading global clinical research and biopharmaceutical services organization that supports pharmaceutical, biotechnology, and medical device companies across the full product development lifecycle. The organization provides expertise across clinical development, regulatory affairs, pharmacovigilance, medical communications, and market access, working with clients worldwide to advance creative healthcare products and therapies.

Key responsibilities:
- Coordinate end-to-end Clinical Trial Application (CTA) submissions across the EU, UK, Ireland and ROW markets.
- Participate in Study Kick-Off Meetings (KOMs) with Global Regulatory Leads and study teams.
- Develop, review and coordinate regulatory submission content plans and deliverables.
- Review CTA documentation for completeness,



accuracy and structural compliance.
- Prepare and coordinate EU CTA submission packages and supporting documentation.
- Manage CTIS submissions, including application updates throughout the submission lifecycle.
- Support UK CTA submissions and amendments through the relevant regulatory processes, including IRAS.
- Coordinate Ireland and ROW clinical trial regulatory submissions with local country teams.
- Coordinate central submission packages and dispatches with global and local regulatory teams.
- Support the preparation and management of CITRIS packages, where applicable.
- Coordinate and track CTA amendments across multiple countries and regulatory jurisdictions.
- Manage Health Authority Requests for Information (RFIs), queries and HAQs from receipt through resolution.
- Coordinate preparation of RFI responses, cover letters and supporting documentation with relevant stakeholders.
- Maintain accurate submission

📌 Clinical Trial Regulatory Submission SME (Gurugram)
🏢 Apsida Life Science
📍 Gurugram