Senior Regulatory Specialist

Discover International; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Discover International is seeking a Clinical Regulatory Operations Specialist to join a long-term engagement. This role focuses on executing regulatory submissions across Europe, the UK and ROW, with hands-on experience in CTA submissions and RFIs.

You will work closely with global regulatory teams, leveraging Veeva Vault and other systems to ensure timely approvals. The ideal candidate has proven experience in regulatory operations, strong organizational skills, and the ability to manage

Qualifications

• Hands-on Regulatory Operations experience in clinical trials.
• Experience with CTA submissions across multiple regions.
• Practical exposure to CTIS and/or IRAS processes.
• Experience coordinating submissions from preparation to approval and managing RFIs.

Responsibilities

• Manage Clinical Trial Application submissions and amendments.
• Support EU submissions through CTIS.
• Manage UK submissions through IRAS.
• Prepare and coordinate regulatory submission packages.
• Review and approve content plans and submission documentation.
• Coordinate with central and local regulatory/study teams.
• Manage Health Authority RFIs / queries.
• Maintain submission trackers, regulatory systems and documentation.
• Support submission acknowledgements, approvals and archival.
• Work with Veeva Vault and other regulatory systems.

Skills

Regulatory operations

CTA submissions

RFI management

Cross-functional coordination

Regulatory submissions

Tools

Veeva Vault

Job description

Clinical Regulatory Operations Specialist

I’m currently supporting an our client for a long-term Clinical Regulatory Operations engagement for an experienced regulatory professional with strong hands-on clinical trial submission experience.

This is an operational role for someone who enjoys being directly involved in the execution of regulatory submissions across Europe, the UK and ROW.

Key responsibilities

• Manage Clinical Trial Application (CTA) submissions and amendments
• Support EU submissions through CTIS
• Manage UK submissions through IRAS
• Prepare and coordinate regulatory submission packages
• Review and approve content plans and submission documentation
• Coordinate with central and local regulatory/study teams
• Manage Health Authority RFIs / queries
• Maintain submission trackers, regulatory systems and documentation
• Support submission acknowledgements, approvals and archival
• Work with Veeva Vault and other regulatory systems

What we’re looking for

• Proven hands-on Clinical Trial Regulatory / Regulatory Operations experience
• Strong experience with CTA submissions
• Practical experience with CTIS and/or IRAS
• Experience managing regulatory submissions from preparation through to approval
• RFI / Health Authority query management experience
• Veeva Vault experience highly desirable
• Experience working across EU, UK and/or ROW submissions
• Strong organisational and stakeholder-management skills
• Available to start ASAP

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