Ryan has worked for Cell and Gene Therapy Catapult (CGTC) for the last 7 ½ years in various senior roles, including Senior Development Scientist and Technical Lead Scientist. During his time in these roles, Ryan supported projects comprised of multi-functional teams, which introduced him to, and stimulated his interest in, the role of the Regulatory Affairs (RA) professional.
As part of his personal development plan, CGTC offered Ryan the opportunity to explore his interest in the RA role further by committing 25% of his time to support regulatory focused projects. This led to Ryan applying for an internally offered Level 7 Regulatory Affairs Specialist apprenticeship opportunity, as a full-time vacancy through the Advanced Therapies Apprenticeship Community (ATAC). As the successful candidate, Ryan then joined the CGTC regulatory affairs team, where he has been in post for the last 18 months.
Transitioning to a completely new role provided Ryan with the time he required to engage with his apprenticeship, receive on-the-job training and upskill. Alongside the apprenticeship, apprentices have the opportunity to complete an MSc in regulatory affairs at an additional cost; Ryan is grateful to CGTC for fully funding this aspect of his development, including the cost of travel and accommodation for attending face-to-face elements of the apprenticeship program. This apprenticeship is offering Ryan the opportunity to enter a field where there is high demand for skilled talent driven by the growing number of advanced therapies progressing through the clinical phases and moving towards commercialisation.
An apprenticeship with impact
When asked about his experience of the apprenticeship, Ryan commented:
“The perception of apprenticeships needs to change. Apprenticeships support people at any stage of their development or career and are a brilliant way to put theoretical learning into immediate practice. In my opinion, the value of knowledge and experience gained through apprenticeship programs should be given equal recognition by employers to that of more formal degree programs.”
“The lunch and learn webinars from ATAC have been a valuable resource for gaining insight from other professionals who are part of the broader network. I have enjoyed listening to their perspectives on a variety of topics. ATAC is certainly a good way of making connections and provides a great support network for its members.”
“I certainly believe that both myself and CGTC are benefitting from the apprenticeship. My prior experience of regulatory affairs (from the projects I supported whilst exploring the field during previous roles), whilst not essential, was valuable in enabling me to contribute from the outset and be committed to the team and programme straight away. My experience and pro-active approach meant I had a level of autonomy that reduced the amount of support needed compared to someone new to CGTC or the industry. I also feel valued by being supported with my development. Whilst, CGTC sees the benefits of investing in senior leaders and retaining employees within the organisation.”
“I would say definitely engage with the apprenticeship program… whether you are thinking of upskilling or if you an employer wanting to develop your people!”
The next steps
After completing my apprenticeship, I intend to stay at CGTC to continue building my knowledge and experience related to the regulation of ATMPs.
“The apprenticeship program has been a great mechanism for me to transition into a new role and upskill, whilst remaining at CGTC and continue supporting collaborators within the ATMP community.”
About the Level 7 Regulatory Affairs Specialist apprenticeship
A Regulatory Affairs Specialist is responsible for developing and implementing strategies that allow a company to legally develop, manufacture, market and supply healthcare products and critically evaluate the evidence generated during the development and use of products for its suitability to support obtaining and managing marketing authorizations and approvals for clinical studies in line with legal requirements. A Regulatory Affairs Specialist may also work within service companies offering consultancy support to manufacturers or in the relevant competent authorities or Notified Bodies where they will be assisting in the review and assessment of regulatory and technical dossiers prior to issuing a licence.
This programme is provided at Masters level through TOPRA (The Organisation for Professionals in Regulatory Affairs) and is 26 to 30 months in duration. Typical job roles that this programme is suitable for may include: Regulatory Associate, Strategist, or Executive, Regulatory Affairs Manager, Regulatory Compliance Professional, Medical Device Competent Person.
About Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 300 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.
Supported by the Advanced Therapies Apprenticeship Community (ATAC)
An advanced therapies apprentice enjoys access to a wide variety of support provided by ATAC including:
- Access to learning resources and technical webinars from industry experts
- Optional cohort days for apprentices from different organisations to meet, share their experiences and collaborate
- Advice for professional development, such as presenting and networking
- Membership to a network of apprentices, employers, and training providers across advanced therapies
- Access to the ATAC App for further information, resources, community connections and more!
Developing skills and employability for the future
ATAC has prioritised a range of programmes, from entry-level to Master’s-equivalent apprenticeships, to bring in new talent and upskill staff for the rapidly growing UK cell and gene therapy industry. The number of ATAC apprentices more than doubled in one year, now standing at 136 apprentices employed across 36 UK companies, and the initiative continues to provide a platform for developing industry innovators of the future.