Senior Regulatory Affairs Associate- Clinical Trial Application

Overview

Lead end-to-end Clinical Trial Application project management across EU CTR and Rest of the World regions, coordinating global teams and regulatory documentation to deliver timely, high-quality, compliant submissions.

What you'll do

• Lead end-to-end Clinical Trial Application project management across multiple studies and countries, ensuring alignment with timelines and regulatory requirements.
• Plan, track, and deliver submissions across EU CTR and Rest of the World regions with attention to compliance and quality standards.
• Manage risks, dependencies, and complexities in global regulatory environments through proactive identification and mitigation strategies.
• Apply knowledge of EU CTR and Rest of the World CTA requirements to ensure submissions meet regulatory expectations.
• Manage core clinical and regulatory documentation, maintaining accuracy and completeness throughout the submission lifecycle.
• Collaborate with cross-functional global teams including clinical, regulatory, and operations to coordinate submission execution.
• Build and maintain stakeholder relationships across internal and external partners, resolving conflicts and ensuring alignment.
• Monitor key performance indicators related to submission timelines and deliverable quality, driving continuous improvement.
• Identify emerging risks and lead quality investigations as needed to maintain submission integrity.

What you'll need

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar regulated environments.
• Demonstrated experience in Clinical Trial Application submissions across EU CTR and Rest of the World.
• Strong project management experience in global and matrix environments.
• Knowledge of clinical trial processes and regulatory requirements.
• Strong communication, organization, and problem-solving skills.
• Strengths in project management, regulatory knowledge, and stakeholder engagement.
• Experience working in clinical research, pharmaceutical, or CRO environments.
• Ability to collaborate across global teams and communicate clearly with diverse audiences.
• Patient-focused mindset and strong attention to detail in regulatory submissions.
• Comfort working with clinical trial management systems and regulatory documentation platforms.

Nice to have

• Advanced degree or professional certification in regulatory affairs or clinical research.
• Experience with regulatory submission systems and electronic trial master files (eTMF).
• Familiarity with ICH-GCP guidelines and international regulatory pathways.
• Experience managing submissions across multiple therapeutic areas or study phases.

Details

• Remote role.
• Location: Bengaluru, India.