PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
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.
Job Description
• 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
Candidate Profile
• 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
Additional Information
Job ID : R0000038452
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th June 2026
Senior Regulatory Affairs Associate : Apply here
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