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.

Regulatory Affairs Manager

Updated: November 17, 2020
Location: Farnborough, ENG, United Kingdom
Job ID: 128375

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.

 

Responsibilities

  • Part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for Kinapse’ Global client.
  • Responsible for managing project deliverables in line with the project plan.
  • Oversight of initiation, execution and completion of projects for Kinapse’ clients and ensuring delivery is within time and budget; if not, take corrective action.
  • Perform content technical review of work by other team members on an ongoing basis.
  • Act as subject matter expert and help team members with day-to-day trouble shooting activities.
  • Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
  • Keep a vigilant eye on changing processes in industry and suggests areas for improvement in internal processes along with possible solutions.
  • Communicate effectively with internal clients to identify needs and evaluate alternative business solutions.

Job Requirements

  • Relevant experience in Regulatory affairs and labelling, with exposure to regulatory filings as a part of a pharmaceutical company or CRO.
  • Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
  • Experienced people manager.
  • Significant knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
  • Ability to motivate team members, provide coaching and support development, troubleshooting, tracking deadlines and acting as a primary or second degree reviewer.
  • Excellent written communication skills.
  • Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel.

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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