CMC Associate Director - Biologics & Monoclonal Antibodies Work

Sep 11, 2019
Oct 11, 2019
EL. 206323.33
Edward Little
Jobseeker Type
Organization Type
Clinical Practice
Contract Type
Full Time

NonStop Pharma are currently working with an innovative, cutting edge Biologics company to find a Regulatory Affairs Associate Director to Lead CMC.

The Regulatory Affairs - CMC Associate Director will independently manage all regulatory CMC aspects of assigned products throughout their lifecycle. This includes Biologics, Small Molecule, and Drug/Device combinations.

Multiple office locations are available, including the Home Counties & Scotland. The latter, based in a beautiful, quiet and scenic location in Scotland, this is a lovely environment to work in. Just a short train journey from Edinburgh, this location offers both rural peacefulness with access to the city.

Our client is going through an exceptional time. With our imminent rare disease product launches and further new product development combined with excellent international growth rates, they are providing a great platform for today and future.

Substantial reinvestment into R&D means ongoing creation of products at both early and late stage development. This prosperous time includes developing new teams, new departments and moving into exciting new areas. For this reason it's a great time to join and become a key figure in the business growth.


- Be a part of exceptional company growth

- Develop your career with excellent progression opportunities due to an increase in funding and growth

- Work with an innovative, cutting edge company with imminent rare disease product launches

- Play a key role in patient welfare via pioneering and ground breaking drug development

- Excellent employee benefits such as a competitive salary, pension scheme, private medical insurance etc.

- Join a company with a modern, flexible and fun company culture


  • Extensive pharmaceutical industry experience and regulatory CMC experience
  • Bachelor's degree in a relevant scientific discipline. Master's or an advanced degree (PhD, Pharm D, MD) is preferred.
  • Ability to conduct critical evaluations of analytical data and set clinically relevant specifications.
  • Expert knowledge of the fundamental principles of pharmaceutical drug substance/drug product CMC development.
  • Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
  • Prior experience with authoring, submission, and approval process of a major biologic marketing application

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

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