This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Associate based in India.
This role offers the chance to lead the planning, coordination, and execution of clinical trial submissions across multiple countries and regulatory environments. You will manage Clinical Trial Applications (CTAs) from end to end, ensuring submissions are timely, accurate, and compliant. Working across EU CTR and Rest of World (ROW) requirements, you will navigate complex regulatory landscapes and proactively manage risks and dependencies. The position involves close collaboration with global clinical, regulatory, and operational teams. You will also build strong stakeholder relationships, monitor submission performance, and drive quality improvements. This is a high-impact opportunity to contribute to the efficient advancement of clinical development programs and, ultimately, therapies that benefit patients.
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Accountabilities




Lead end-to-end Clinical Trial Application project management across multiple studies, countries, and regulatory environments.
Plan, coordinate, track, and deliver clinical trial submissions in accordance with regulatory requirements and agreed timelines.
Apply strong knowledge of EU Clinical Trials Regulation (EU CTR) and relevant Rest of World CTA requirements to support compliant submissions.
Manage submission documentation, dependencies, risks, issues, and complexities across global regulatory projects.
Coordinate effectively with cross-functional and geographically distributed teams to ensure submission deliverables are complete, accurate, and delivered on schedule.
Build and maintain productive relationships with internal and external stakeholders, facilitating alignment and resolving conflicts when required.
Monitor key performance indicators related to submission timelines, deliverable quality, and project execution.
Identify potential risks proacti

📌 Senior Regulatory Affairs Associate (India)
🏢 Jobgether
📍 India