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 (Remote)

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Updated: January 18, 2021
Location: New York, NY, United States
Job ID: 129320

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.

Regulatory Managers play an important role in executing regulatory outsourcing programs for Kinapse’s global clients. The Regulatory Affairs function sits within the CMC, RA and Publishing Service Line within Kinapse and is responsible for all things regulatory apart from CMC authoring and Publishing eg. authoring of Module 1, collation of all ancillary documentation, overall collation of the final dossier, leading the preparation of labelling and safety variations liaison with the client and potentially their affiliates, tracking of submissions and loading data onto client tracking systems etc.

This role is home-based in the US. There may be visits potentially to the offices of clients.  

 

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 with exposure to regulatory filings as a part of a pharmaceutical company is preferred.
  • 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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