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 Associate
Job ID R0000043744 , IndiaKey Responsibilities
- Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
- Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
- Manage and maintain regulatory change records within Veeva RIMS.
- Support implementation of regulatory strategies for post-approval changes.
- Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
- Ensure CMC documentation remains current and compliant with regulatory expectations.
- Support dossier lifecycle maintenance activities across multiple markets.
- Conduct comprehensive Gap Analysis of Module 3 documentation.
- Identify compliance risks, data gaps, and documentation deficiencies.
- Develop and recommend remediation plans and regulatory strategies to address identified gaps.
- Manage post-approval regulatory activities throughout the product lifecycle.
- Support maintenance of marketing authorizations across EU markets.
- Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.
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