CK Group are recruiting for a Regulatory CTA Submission Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 3 months.
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies.Location:
This CTA Submissions Manager role will be based at our clients site in High Wycombe, Buckinghamshire. Salary:
£64.51 per hour PAYE / £86.67 per hour Ltd.Regulatory CTA Submission Manager Role:
This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
The Regulatory CTA Submission Manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial. Your Background:
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
- Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry.
- An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
- Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
- Ability to lead complex projects and a high degree of problem solving capability required.
For more information or to apply for this Regulatory CTA Submission Manager position, please contact CK Group, quoting job ref 48742.
It is essential that applicants hold entitlement to work in the UK.