Senior Regulatory Affairs Associate- Clinical Trial Application

Role & Responsibilities

• Manage end-to-end Clinical Trial Application (CTA) submissions across global regions, with a strong focus on EU Clinical Trial Regulation (EU CTR).
• Prepare, review, compile, and submit Initial CTAs, Part I and Part II submission packages through CTIS.
• Coordinate and manage Substantial Modifications (SM), Non-Substantial Modifications (NSM), End of Trial (EOT) notifications, and Transitional Studies.
• Support preparation, compilation, validation, and submission of regulatory documentation in accordance with EU CTR requirements.
• Manage and respond to Health Authority Requests for Information (RFIs), including validation and assessment RFIs.
• Monitor CTIS notices, alerts, submission timelines, and regulatory decisions.
• Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Medical Writing, Safety, Data Management, and external stakeholders.
• Ensure submission readiness, document quality, completeness, and compliance with applicable regulations and SOPs.
• Maintain submission records and support lifecycle management activities through CTIS and associated regulatory systems.
• Track multiple studies simultaneously and proactively manage risks, timelines, and submission deliverables.
• Support client and Health Authority interactions related to CTA activities as required.

Preferred Candidate Profile

• Bachelor's or Master's Degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, or a related discipline.
• Minimum 4 years of hands-on Clinical Trial Application (CTA) experience.
• Strong experience with EU Clinical Trial Regulation (EU CTR) and Clinical Trial Information System (CTIS).
• Proven experience managing Initial CTA submissions, Part I, and Part II submissions.
• Hands-on experience with:
• Substantial Modifications (SM)
• Non-Substantial Modifications (NSM)
• End of Trial (EOT) submissions
• Transitional Studies (EUCTD to EUCTR)
• Experience handling Health Authority RFIs, CTIS alerts, notices, and submission tracking activities.
• Ability to independently manage multiple studies and end-to-end CTA submission activities.
• Experience with Veeva Vault RIM, Veeva Vault Clinical, CTIS, CARA, EudraCT, CESP, IRAS, and MHRA Portal is preferred.
• Experience in Pharma, CRO, or Clinical Research organizations supporting global clinical trial submissions.
• Strong project management, stakeholder management, communication, and problem-solving skills.

Mandatory Skills

CTIS, EU CTR, Initial CTA, Part I, Part II, SM, NSM, EOT, Transitional Studies, RFI Management, Health Authority Responses, Clinical Trial Applications (CTA), Veeva Vault RIM, EudraCT, CESP, IRAS, MHRA Portal.

Profiles Not Suitable

Regulatory Publishing (eCTD, Hyperlinking, Bookmarking)

Regulatory Operations without CTA ownership

RIM/Data Governance profiles

Medical Device Regulatory Affairs (MDR, IVDR, IVD, SaMD)

eTMF-only profiles

Clinical Operations profiles without CTA submission experience

Pure CMC/Product Regulatory Affairs profiles