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 Consultant (CMC Regulatory Affairs)

This job posting is no longer active

Updated: October 20, 2020
Location: Gurgaon, HR, India
Job ID: 127773

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 Senior Consultant (CMC Regulatory Affairs) to be based in Gurgaon or Bangalore.

Responsibilities

  • Undertake project specific activities independently.
  • 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.
  • Proactively identify moderately complex issues and risks to project delivery in own work or work of the team and escalate appropriately with associated resolution proposals.
  • Assist the team lead in delivery through work allocation, develop project plans, compilation, tracking, process implementation/compliance, review and reporting of the project reports on timely basis.
  • Participate in meetings with Client on a regular basis to understand the client’s requirement for a particular project and proactively support the team in meeting or exceeding the targets in terms of quality and quantity.
  • Recommend time lines and change in requirements.
  • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities.

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.
  • Ability to lead / mentor junior team members.
  • Ability to provide effective customer and stakeholder communications.
  • Working knowledge of basic office applications, e.g. MS Word/ PowerPoint/ Excel will be required.

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

Click here to enable personalized experience

Tell Us About Your Candidate Experience! Get In Touch