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 R0000040066 , IndiaUS & Canada Annual Report
- Compile list of Annual Reportable or Submitted/Approved CMC Changes.
- Strategy/Alignment Meetings (either actual meeting or e-mail exchanges).
- Prepare/Populate CMC Submission Content Plan (“SCP”) Preparation & Submission.
- Activities Module 1 authoring Liaise with appropriate functions to collect all required information to submit.
- Populate the SCP, including e-CTD attributes.
- Liaise with Regulatory Operations to ensure the publishing order and dispatch of CMC Dossiers.
- Follow-up with the Country Regulatory Manager (Affiliate) regarding receipt, submission, and acknowledgement by the Health Authority.
- Store all CMC Dossier and Administrative Documents in the appropriate repository system and close Regulatory Events in RIM.
- Simple Report includes up to 20 reportable changes and Complex Report includes up to 40 reportable changes.
Ideal Candidate Profile
- 5+ years of experience in Regulatory Affairs (Pharma).
- Understanding of US & Canada regulatory requirements for pharmaceuticals.
- Experience in module 1 authoring.
- Ability to handle multiple projects and meet submission deadlines.
- Comfortable working in a fast‑paced, compliance‑driven environment.
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