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 Scientist, Non-Clinical Regulatory

Updated: April 8, 2021
Location: Gurgaon, HR, India
Job ID: 131848


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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

  1. Project Delivery
  • Manages non-clinical project deliverables and submission content in line with project plan
  • Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals
  • Undertakes project specific activities independently and within cost and time estimates
  • Responsible for process implementation and ensure process compliance .
  • May support the Manager or Senior Manager in delivery and/or the successful initiation, execution and completion of non-clinical regulatory services for Kinapse’ Global clients
  • May be responsible for reviewing submission output from team members.
  • May assist in work allocation, compilation, tracking and reporting of the project reports on timely basis
  • Applies negotiation skills to recommend time lines and change in requirements
  • As applicable, author non clinical regulatory documents which meet agreed quality standard as agreed with client within stipulated time and cost.
  • Should be acquainted with detail of various regulatory agency’s non-clinical safety requirements and GLP/GXP regulations.
  • As applicable, author and review the protocols and study reports as well as other essential documents required in non-clinical studies.
As applicable, author and review non-clinical packages for submission to Health Authorities.


2. Problem Solving and Analysis
  • Exhibits a growing awareness of project strategy and thinking capability alongside independence
  • Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required 


3.  People Development
  • May be involved in people development in partnership with PDG leads
  • Provide training and mentoring of team members depending upon the project requirement


4.  Training Compliance 

  • Ensure that all training (Kinapse internal training and client training) are successfully completed in a timely manner

Job Requirements

  • Post Graduate with Masters in Pharmacy or D/ Post Graduate degree in Life Sciences 
  • Experience in non-clinical regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical or generic company are preferred
  • Understanding of toxicological studies required to support clinical trials including genetic and general toxicology studies and nomenclature
  • Knowledge of non-clinical regulatory requirements and/or guidelines (ICH, GCP) and exposure to relevant document management systems are preferred.
  • Good oral / written communication skills
  • 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


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