Global Regulatory CTA Lead – Global CRO – Remote (UK / EU only) - £competitive, bonus, benefits
This is an exciting time to join this market leading, global CRO based in the UK / EU. You’ll predominantly operate as regulatory operational Subject Matter Expert for CTA’s and drive submission teams towards the timely delivery of globally compliant submission-ready components.
A global, well known CRO are now recruiting for a Global Regulatory CTA Lead to join their already well-established team. You’ll be working directly with one of their major pharmaceutical clients on an exciting pipeline of new products. Offering great training and development, this company has a huge interest in developing their employees to a high standard.
- Global CRO
- Working across exciting projects with one major client (global pharma)
- Excellent career progression opportunities to Senior Manager, Associate Director and beyond
- Great training and development
Working on a number of exciting projects for one major pharmaceutical client, the Global Regulatory CTA Lead will be responsible for;
- Driving global submission management strategy and activities for assigned protocols.
- Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
To apply for this role as Global Regulatory CTA Lead our client is hoping for someone with the following skills and experience
- Ample CTA Regulatory experience on a global basis
- Degree in scientific discipline or advanced degree
- Study Start UP (SSU) experience will also be considered (global only)
- Thorough understanding of the drug development process for all phases of pharmaceutical development
- Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance
What should you do next?
This Global Regulatory CTA Lead role is one not to be missed; it encompasses the opportunity to work on a highly successful team on some new and exciting products with one major pharmaceutical client. To discuss this Regulatory CTA Lead role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.