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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Associate
Job ID R0000042663 , IndiaJob 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 3+ 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
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