Associate CMC Regulatory Director ** Northern Home Counties ** Early Dvlpt ** Gain Global *

Reference: MG031221B

Expiry Date: 11-03-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Welwyn Garden City
United Kingdom

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Job Description

This is a rare opportunity to join a company entering its growth phase, as it transitions from being a discovery company to a high potential drug development company, with their headline NMEs now entering Ph 1a/b. This will appeal to you if you want to work in an organization at the very beginning of this transition, knowing it is well-funded, led by big pharma oncology leadership (including the line manager) with their know-how, but still in its infancy – you will be here as one of the first few hires in regulatory, so you will help grow and shape not just the pipeline but also the company and culture, systems and process.

Why consider this role?

  • Company has brought 4 NMEs into clinical phase 1 and has partnered some of these compounds with top 5 oncology powerhouses – there are multiple other NMEs and new targets translating through – you will lead their programs as a CMC regulatory lead
  • You want to be one of the early founding employees in a company where everyone gets stock options, the organization have around 120 employees right now
  • You will be happy to attend their site in a semi hybrid model, which is based in Herts / Cambs borders and easily commuted from Bucks, Beds, Cambs, Herts, Essex or North London
  • Reports directly to a Head of Regulatory, you will be one of their first hires in regulatory and will be part of the creation team, which helps bring the NMEs into clinic, identify adaptive or fast track / prime designation, orphan and eventually co-lead your NME into pivotal study and filing
  • The role is global, in fact, even though this role is in the UK, my client would like it if you had expertise in US INDs not just CTA/IMPDs this would be very useful
  • Truly innovative and first in class drug development platform which joins small peptides to chemical therapies, smaller than an ADC but in some ways offering much more flexibility, no identified immunogenicity and a better ADME profile potentially that ADCs, NCEs, and mAbs
  • Company has several compounds coming into or in Ph 1, you will be part of a small team which builds the road, not just travels it, and be happy working on department initiatives, managing CDMOs, CROs and consultants and working in a smaller more nimble company (the CMC subteam is already hired, except of course this role the regulatory CMC lead).


What this role is doing?


  • You will provide both some strategy and operational coordination and execution of regulatory CMC plans, coordinating , compiling, reviewing and submitting INDs, IMPD/CTAs as well as Expert Reports for Health Authority questions  (the MOA and modality is novel)
  • As the company is in clinical phase, IMPDs is prioritized over MAA experience, knowledge of scale up, and a cellular or molecular, or previous experience in analytical or a MSAT science for a biotechnology product would be useful
  • You will help to prepare and support overall CMC regulatory strategy, but this is not a pure strategy role, and between you and the CDMOs and CMC team, the dossiers have to be compiled but impact assessment and regulatory requirements will also have to be fed in
  • You will support health authority interactions, Scientific Advice, and manage responses to HA questions for CMC related issues, bearing in mind this is a novel molecule type
  • The role is going to grow as the pipeline grows, and you will be mentored and developed by an ex oncology powerhouse line manager, who has worked in oncology and other TAs, is very down to earth, pragmatic, not a suffocating manager, who will hone your capabilities and grow your depth of knowledge and experience


Your Background & Skills 

  • Around 5 years or more in drug development CMC regulatory affairs, backed up by a higher degree ideally  - gained with either a CDMO, CRO consultancy team or a bio-/pharma

Ability to work in a company which is not a start-up, but is now changing into a clinical phase drug development company, so you will need to be adaptive, able to build processes as you go, and have a collaborative manner in working (some of your peers are very strong scientists and functional experts).


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or my colleague Matt Greig on +44(0) 207 801 3386. We will support you throughout the interview and on-boarding experience.

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