Regulatory Affairs Process Optimisation Lead

Highly Competitive
  1. Permanent
  2. Operations
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 28 May 2019

A historic pharmaceutical company is advertising a vacancy for a Regulatory Affairs Process Optimisation Lead position, to be based in the company's office in Cambridge. This organisation prides itself on its presence in the fields of antisepsis, respiratory, oncology, pain, and consumer healthcare, along with other speciality areas. With over 4,500 employees across the emerging markets, this organisation represents an exciting opportunity to bolster work with patients on a global scale and bolster a career in the regulatory field.

The Process Optimisation Lead will lead and oversee regulatory operational activities and deliverables in line with business priorities. They will ensure that Regulatory Affairs operational activities are delivered via efficient & optimised processes as per agreed timelines. Finally, the Regulatory Affairs Process Optimisation Lead will manage the RA forecast prioritisation and ensure effective and quality delivery from external vendors.

Job Responsibilities:

  • Ensuring RA operational activities are delivered as per agreed targets in a consistent and efficient manner and with the right quality.
  • Ensuring operational excellence in delivery of regulatory output by external vendors.
  • Utilising effective processes and adequate oversight, and in collaboration with the asset regulatory and/or project leads, ensuring operational delivery is in alignment with product regulatory strategies and business needs.
  • Implementing RA forecasting and planning and ensuring effective prioritisation of the workload.
  • Acting as the initial escalation point for Regulatory Affairs Process related queries from within the organisation and from vendors.
  • Providing effective RA knowledge and process expertise to ensure vendors are providing effective, efficient service and are utilising processes optimised for the company.
  • Overseeing RA delivery services from vendors to ensure that they are fit for purpose and in line with the direction provided.

Skills and Requirements:

  • Broad understanding of various aspects of RA and excellent knowledge of RA processes.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joe Beddows at +44 203 854 2623 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.