Louise Kneebone – Develop in PharmaLex

Regulatory CMC Compliance reduced risk

I have worked for PharmaLex for nearly 10 years and I have been developed through training and mentoring constantly during that time. 

I started my career at a CMO (Contract Manufacturing Organisation) working at a lab bench purifying monoclonal antibodies. When my son was born, I relocated to Cornwall and as such had to do a complete career change (because there are no laboratories on the beach!). PharmaLex is a global company with a local presence, and I was delighted that the Cornwall office was taking on new starters when I finished my maternity leave.  

I arrived at Pharmalex with Industry Experience, but no specific Regulatory knowledge and benefitted from the comprehensive induction package provided by our PharmaLex Academy. Over the years this training has been developed and refined and has been specially designed for new entrants to the field of pharmaceutical regulatory affairs. 

In addition to the basic training, for many standard regulatory affairs processes we have detailed SOPs and templates, so from the first project, new starters are able to produce high quality work that fits seamlessly into a submission. 

In addition, we have a full peer review process where each piece of work is reviewed by another member of the team. 

We pride ourselves on ‘right first time’ and so we can deliver this, any minor errors are picked up in-house and corrected at the peer review stage rather than with the clients or the Agencies. 

This also means that new starters can feel confident that their understanding and execution of each piece of work is correct. 

 As you progress through your career, the Advanced training package then provides more focused, specific, and specialized training in Regulatory Affairs, but also in such diverse areas as Finance, Project Management, IT skills and even languages.  

 As an international company, in the first 5 years at PharmaLex I worked on exciting projects such as: 

  • Renewals in Central and French West Africa 
  • Source Transfers in Asia Pacific Markets 
  • Tablet coating changes in Russia 
  • Patient Information updates in Germany 

During this time, I was promoted to Senior Specialist and in addition to in-house training, I benefitted from professional training with TOPRA (The Organisation for Professionals in Regulatory Affairs). Regulatory Affairs professionals need to keep abreast of changes to regulations and are constantly improving their knowledge and expertise. 

The Advanced training package is constantly evolving and as an example of PharmaLex on the cutting edge of Regulatory Affairs, we now have a training module in ‘Emergency use vaccine development’! 

After the birth of my daughter and an extended maternity leave, I jumped right back into work and was rewarded with new interesting projects including working as the UK Affiliate for a large pharmaceutical company. Work-Life balance is respected and encouraged at PharmaLex. 

We have the opportunity for flexible working hours and the opportunity to work from home. 

Up until recently I have always worked part-time. I now have 3 children and each time my personal circumstances have changed – I have fitted my working patterns around them. When my son went to school I increased my hours, and then when my daughter was born, I reduced them back down again. Now my daughter is at school I am working full time and like the majority of the UK, working from home for the foreseeable future. However – communication with colleagues has been unaffected during this difficult time. We have both team building activities and wellness program initiatives in place. These measures support all employees to deliver the best work we can to our clients. 

Working at PharmaLex has been a rewarding experience and I am looking forward to the next 10 years of my career.  

 At the beginning of the pandemic, I was promoted to Regulatory Manager and started working as a Project Manager. I quickly took on more responsibility and with structured training and development, I am now managing several projects with a core team that is spread across 5 countries.  

PharmaLex knows the importance of personnel development and I was delighted to be selected for the Professional Project & Program Management course which will run across 2022. This development program is designed to accelerate potential towards program management capacity and capability and I am looking forward to the training and challenges that the next year will bring. 

Scroll to Top