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.
Regulatory Affairs Consultant- Local Regulatory Affairs Operations
Job ID R0000043366 , IndiaThis role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
Key Responsibilities
• 7+ yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers.
Working knowledge on EU procedures including centralized procedures coordination and management.
• Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s.
• Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up
• Manage submissions through local Health Authority portals as required
• Handle post-approval lifecycle management activities and regulatory communication-RIMS
(Regulatory Information Management Systems)-VEEVA Vault
• Support linguistic review processes including translation review and coordination
• Conduct readability testing and support artwork (AW) review, mock-ups, and approvals
• Support promotional material review including Abbreviated Product Information
(API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)
• Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.
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