Jobs at Parexel
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.
Senior Regulatory Affairs Associate
Job ID R0000036892 , India- 4-7 yrs in-depth knowledge of Indian regulatory guidelines for clinical trials, including NDCT Rules.
- Hands-on experience with SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments.
- Ability to liaise effectively with global sponsors and cross-functional teams.
- Prepare necessary documentation, presentations, and briefing materials for SEC meetings
- Strong understanding of global regulatory expectations and harmonization with Indian requirements.
- Acquired hands-on expertise in managing and completing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal.
- Updated with current Guidelines and Gazette Notifications to give suggestions/comments to respective Regulatory authorities and Govt. regulatory bodies.
- Working knowledge of India regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
- Manage timelines for query responses and ensure on-time submission through SUGAM portal or other regulatory platforms.
- Clear oral and written communication skills
- Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work in different time zones
- Ability to work independently
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