About Me:

I am Ben Ellwood and I have been in the Pharmaceutical Industry for over 34 years with the last 32 years in senior roles in Regulatory Affairs and Strategy within the CRO space. I have a wealth of experience in strategic planning, preparation and coordination of global regulatory submissions leading to successful approvals.

Over the years I have become a recognised SME in the provision of regulatory considerations for clinical trials including strategy, planning, preparation and submission. I have extensive experience in coordinating global study submissions across all phases of development in the EU (including the use of CTIS), non-EU Europe, Asia-Pacific, North America, Latin America and MENA regions including Health Authority interactions for responding to RFIs and ad hoc regulatory queries. 

I have always found that essential to obtaining timely approvals is keeping up to date on the latest Regulatory Intelligence/knowledge. I have considerable experience in Reg Intel gathering including assessing the impact of the latest updates from Regulatory Authority websites, industry body publications and press releases as well as utilising lessons learnt from real life country submission experience in country nuances and trends. I also have experience working on the ACRO Scientific and Regulatory Committee.  

My recent roles have included industry leading extensive deep dive reviews of trial supporting documentation (non-clinical data package, protocol synopsis, IB, PIPs, CMC, clinical data etc) to pre-identify likely regulatory hurdles/data gaps vs guidance and submission experience. This allows a bespoke best fit regulatory plan to be developed putting you in the best possible position to achieve expedited approvals. I also have considerable experience in the planning, collection and analysis of METRICS e.g Reg/EC approval timelines and timelines to site initiations, all of which are vital tools in streamlining the planning and submission process. 

As Regulatory lead, experience has shown a critical component to timely trial start up success is effective cross functional collaborations. Thus effective and timely communications with external sponsors, internal departments such as project management, bio-statistics and feasibility as well as with Heath Authorities for pre and post submission Interactions are essential.

I have extensive leadership and line management experience within Regulatory Affairs including 8 direct line reports-overseeing both departmental growth and individual development. I have substantial experience in the recruitment of new staff as well as regulatory on-boarding and training to teams including on topics such as EU CTR, Paediatric considerations for studies, ODD strategy, country nuances and the evolving UK Clinical Trial environment.  

As well as scientific rigour, I am a strong believer in the effective use of ‘soft skills’ to aid pivotal communication pathways, relationship development and effective project delivery. I have been consistently recognised for fostering and growing strong durable client relationships leading to being the 2012 Covance Way Award Winner-For Leading Advancements in People, Process and Clients.  

Over the last 4 years in CROs, I have taken part in over 100 sponsor Business Development Meetings (BDMs) as Global Regulatory Lead and proudly achieved a >30% win rate.

Check out how I may be able to offer support on the Services Tab.