Clinical Trial Regulatory Submission SME

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 innovative 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 trackers, CTA logs, regulatory records and submission archives.
- Monitor regulatory timelines, approvals, decisions and communications, identifying risks or delays and keeping stakeholders informed.

Experience required:

- Hands-on experience managing Clinical Trial Applications (CTAs) and regulatory submissions.
- Strong experience with EU CTA submissions.
- Hands-on experience using CTIS for clinical trial submissions and lifecycle management.

- Experience with UK CTA submissions and amendments.
- Hands-on experience using IRAS for UK clinical trial submissions.
- Strong understanding of the EU Clinical Trials Regulation (CTR).
- Good knowledge of UK clinical trial regulatory requirements.
- Experience managing Health Authority RFIs, queries and HAQs.
- Experience coordinating submissions across global, central and local regulatory teams.
- Experience managing CTA submission documentation, trackers and regulatory communications.
- Experience working within a pharmaceutical, biotechnology or CRO environment.
- Experience coordinating EU, UK, Ireland and ROW submissions.
- Experience preparing and managing CITRIS packages.

- Experience with Veeva Vault and regulatory Content Plans.

- Experience with SCP, GRSP and DER processes, as well as clinical trial transparency systems

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.