Kinapse

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

Senior Associate - Regulatory (Publishing)

Updated: March 30, 2021
Location: Gurgaon, HR, India
Job ID: 129694


Not ready to apply?
Join our Talent Network

Overview

Job Summary

Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognize our people by providing valuable benefits and a quality of life balance.

An opportunity has arisen for a Senior Associate to be based in Gurgaon or Bangalore.

                                                 

Responsibilities

  • Support the publication of high quality regulatory submissions to health and regulatory authorities worldwide.
  • Publish quality submission outputs in accordance with agreed processes, timelines, formats and standards.
  • Input into all Kinapse and client publishing services quality and tracking systems.
  • Actively participate in development, review and process improvement activities.
  • Ensure each submission package is correct and in the required format and delivered in a timely manner to expedite publication.

 

Job Requirements

  • Good working knowledge of less complex tools/systems used in support of publishing processes, in particular eCTDXpress, ISIPublisher, ISIToolbox and Compose.
  • Experience in Documentum-based dossier repositories.
  • Good understanding of existing regulatory agency standards and formats for submission.
  • Good knowledge of ICH/regional eCTD guidelines
  • Strong communication skills (both written and verbal).
We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organisation. To review our D&I policy please visit  https://kinapse.com/diversity-inclusion

 


Not ready to apply?
Join our Talent Network

Click here to enable personalized experience

Tell Us About Your Candidate Experience! Get In Touch