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Duration: 5 months
The successful applicant would work with the Clinical Trial Team Lead to ensure that appropriate content for specific submissions supporting R&D projects are developed and delivered to agreed timeframes and in compliance with company processes and policies. The role would be for an initial 5 month period but there is some possibility of an extension.
Roles & Responsibilities
• Coordination of CTA Substantial Amendment submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with company policy and procedures
• Accountable to the Clinical Trial Team Lead for overall work plans.
• Accountability for agreed tasks and projects.
• Ensure independent communication, with a range of internal staff, in support achievement of the assigned goals.
• Ensure compliance with CTA and maintenance process through timely action and completion of records in internal systems
• Ensure quality of own work to agreed timeframes, including compliance with systems and record keeping.
Experience & Requirements
• Biological or healthcare science degree or equivalent experience within Regulatory Affairs in the Drug development environment
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to interpret and advise on guidelines and requirements on a global basis
• Ability to build effective working relationships and work in a matrix environment effectively
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Role requires a good understanding of submission requirements for multiple countries/submission types and an ability to work in a matrix environment.
If you are interested in applying for this role, or have any questions, please contact Tom Gordon at CY Partners.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
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