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.

CMC Manager - Regulatory Affairs

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Updated: October 20, 2020
Location: Gurgaon, HR, India
Job ID: 127771

Overview

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 CMC Manager to be based in Gurgaon or Bangalore.

Responsibilities

  • Work on variety of CMC related submissions including but not limited to preparation of components for generating submission ready dossiers such as market accessions, variation dossiers, renewal dossiers, annual reports, health authorities’ questions etc.
  • Review and resolve issues related to project delivery or escalating appropriately to the Team Leader/Program Leader/Program Director as required.
  • Single point of contact for clients, conducting regular meetings to understand the client’s requirements for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
  • Responsible for the performance management of the team on an ongoing basis and the Resource Management of the project.
  • Create high quality reports and other outputs according to the standards and defined specifications to ensure timely reporting of assigned job to project management. 
  • Communicate effectively with internal clients to identify needs and evaluate alternative business solutions.

Job Requirements

  • Relevant experience in Regulatory affairs CMC with exposure to regulatory filings as a part of a pharmaceutical company.
  • Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems.
  • People Management skills with ability to motivate and coach team members.
  • Relevant experience as a primary or second degree reviewer.
  • Relevant experience to support development, troubleshooting, tracking of deadlines etc.
  • Effectively able to communication with customer and stakeholder.
  • We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion

 

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