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 (Labelling)
Job ID R0000035749 Bengaluru, Karnataka, India- Required minimum 4-6 years of experience in development of labeling of drug products (CCDS, USPI, packaging), product package coordination, supply chain regulatory affairs, and quality.
- Good working knowledge of key labeling regulations/guidance, and managing label updates, compliance, and governance.
- Strong knowledge of regulations pertaining to labelling life cycle management in US, EU, Switzerland, Canada and Australia.
- The ability to research and create comparator labeling documents.
- Strong understanding and experience authoring CMC component of Annual Reports.
- The ability to collaborate with technical teams for artwork implementation.
- Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
- Knowledge of usage of Electronic Document Management Systems and / or electronic submission experience.
- Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
- Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
- Monitor, manage and control artwork changes.
- To manage and maintain the Artwork Trackers & Systems.
- To ensure artwork PDFs are maintained and latest versions are readily available.
- Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved
- Experience with consumer advertising and educational materials
- Working experience in Regulatory Information Management Systems (RIMS) like, Veeva, TVT, Docubridge, etc.
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs