CMC Regulatory Manager

  • Freeline
  • Job type: Permanent
  • Closing by 31/10/2019
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Description

Freeline is a privately-held clinical-stage biotechnology company based in the UK and Germany. We have an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment. Freeline has a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs. 

Our gene therapy treatment builds upon the pioneering, world renowned work by the Freeline CSO, Professor Amit Nathwani. His award winning scientific work has already been life changing for patients with Haemophilia B by making gene therapy safe, effective and reliable.

Innovation and entrepreneurial spirit is at our core, but our passion is working together as one team and tangibly making life changing impact. We are therefore looking for talented and passionate professionals who are driven and team orientated. If you share our vision for excellence and are looking for a high paced work environment you may be a great fit for our team.

As part of building our team to support our growing clinical portfolio we are seeking a CMC Regulatory Manager.

The successful candidate will work within the project CMC matrix teams and other regulatory sub-teams to develop CMC regulatory strategy, prepare CMC regulatory documents, participate in regulatory meetings and ensure ongoing compliance with registered details.

This is an exciting opportunity to join a rapidly growing world-class multidisciplinary team and play a pivotal role in developing life changing gene therapy medicinal products.

Role and responsibilities

Provide regulatory input to CMC matrix teams to shape CMC regulatory strategy, including identifying potential regulatory challenges and mechanisms for optimizing the time/cost/risk profile

Co-ordinate the preparation of CMC regulatory documents including managing writing/reviewing timelines and compiling finished documents

Write CMC regulatory documents ensuring required input from scientific staff, including responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents, PIP/PSP, PRIME, Breakthrough/RMAT, etc

Co-ordinate company preparations for CMC meetings with regulatory agencies

Keep abreast of CMC regulatory guidance and disseminate CMC regulatory intelligence to CMC project teams

Work with the Senior Director, Regulatory Affairs to manage and track regulatory submissions and approvals

Ensure ongoing compliance with CMC regulatory filings

Qualifications, education and experience

Strong scientific background and educated to at least degree level preferably in a biological science or pharmacy

At least 3-5 years previous experience of CMC regulatory affairs in a biotech/pharma setting (including writing CMC regulatory documents, participating in CMC regulatory meetings etc)

Experience of providing CMC regulatory input to cross-functional CMC teams

Technical and/or regulatory experience of biologics/advanced therapies desirable

Experience of regulatory strategies for rare disease and/or novel platform development desirable

Experience of late stage development desirable

Required skills:

Excellent interpersonal and communication skills

Excellent written communication and computer literacy skills

Ability to work under pressure to deliver to short timelines

Ability to work autonomously and within a multi-disciplinary and cross-site team environment

Effective time management

Ability to travel to meetings in Europe, US or further afield as the role required

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