Skip Navigation

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 R0000039988 , India

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.

  • EU Single/Workshare/Supergrouped Variation for CP and MRP (N&R and Established products) and HAQ support

  • Coordination of kick-off meeting and any other meeting and follow-ups

  • Reg Vault: creation of RO & SO and Submission content plan

  • Drafting of Cover Letter, Application forms

  • Navigating PLM portal for EU Application form Generation

  • Stakeholder Management

  • Finalization of submission content plans

  • Publishing request and QC of publishing output

  • Managing HA correspondences in Reg Vault

    Shift: 12 pm to 9 pm IST


    #LI-REMOTE

    Join our Talent Community

    Welcome to the Parexel Talent Community! Sign up below and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.

    Recently Viewed Jobs

    You have not recently viewed any jobs

    View all jobs

    RECRUITMENT FRAUD ALERT

    It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.

    @* *@