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 R0000039046 , India- Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines.
- Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault.
- Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs.
- Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions.
- Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics).
- Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications.
- Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities.
- Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management.
- Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS).
- Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions.
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD.
- Hands-on experience with Veeva Vault RIM and regulatory submission tools.
- Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management).
- Familiarity with regulatory systems such as RIMS and DMS.
- Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint).
- Strong analytical skills with ability to collect, interpret, and map complex data.
- High attention to detail and strong organizational skills.
- Effective communication and teamwork abilities.
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