Parexel hiring for Remote location | Senior Regulatory Affairs Associate- Clinical Trial Application

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Post: Senior Regulatory Affairs Associate- Clinical Trial Application

Job Summary:
The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

Key Responsibilities:
• Lead end-to-end CTA project management across multiple studies and countries
• Plan, track, and deliver submissions aligned with timelines and regulatory requirements
• Manage risks, dependencies, and complexities in global regulatory environments
• Apply knowledge of EU CTR and ROW CTA requirements
• Manage core clinical and regulatory documentation
• Collaborate with cross-functional global teams
• Build and maintain stakeholder relationships and resolve conflicts
• Monitor KPIs related to timelines and deliverable quality
• Identify risks and lead quality investigations as needed

Qualifications & Experience:
• Bachelor’s degree in Life Sciences, Pharmacy, or related field
• Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
• Experience in Clinical Trial Application submissions (EU CTR & ROW)
• Strong project management experience in a global/matrix environment
• Familiarity with clinical trials and regulatory processes

Key Skills:
• Project Management & Execution
• Regulatory Knowledge (EU CTR & Global Submissions)
• Risk & Issue Management
• Stakeholder Engagement
• Strong communication and problem-solving skills
• Adaptability, resilience, and teamwork

Primary Location: India, Remote
Job ID R0000044936
Category Regulatory / Consulting