Opportunities for permanent roles in a range of business sectors

Head of CMC Regulatory Affairs

As Head of CMC Regulatory Affairs you will be responsible for the design and transfer of production processes to a GMP environment by setting the regulatory strategy, driving it through to implementation with regular interactions and negotiations with regulatory bodies.

You will be responsible for managing the required analytical activities including method development and validation. You will also be responsible for authoring and reviewing regulatory documentation and correspondence and training of relevant teams and senior management in regulatory and GMP requirements.

Person Specification:

  • Minimum of BSc in relevant life science related discipline with at least 5 years’ experience in CMC
  • Previous relevant experience in GMP compliance and CMC strategy and implementation having worked in biotechnology or pharmaceutical industry
  • Understanding of requirements for safe scale-up of biochemical processes
  • In depth understanding of relevant GMP requirements for manufacture of APIs for use in clinical trials
  • In depth understanding of relevant regulatory requirements for manufacture of APIs for use in clinical trials
  • An excellent project manager with ability to multitask (managing multiple projects at a time, with ability to prioritise)
  • Excellent communication skills (both written and verbal)

In return we offer a competitive salary and comprehensive benefits package.