Regulatory Clinical Strategy
3 weeks ago
Regulatory Clinical Strategy & Submissions Manager
Job Type: Contract
Regulatory Clinical Trial Strategy & Submissions Manager
12 month contract
Berkshire based – Hybrid working
00 Per Hour via PAYE
ASAP start
CPL Life Sciences have been lucky enough to partner with a truly innovative pharmaceutical company supporting in providing medicines across immunology, oncology & neuroscience. Working initially on a 12 month contract the Regulatory Clinical Trial Strategy & Submissions Manager will be delivering Regulatory CTA strategies and operations. Deliver CTA regulatory strategies & operations for a designated portfolio of development compounds
– Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial Regulation) and company procedures.
– Assess scientific data provided by subject matter experts against CTA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses
– Author EU Clinical Trial Application forms, review CTA documents to ensure compliance with current requirements
Must be able to commit to commuting Berkshire office twice per week
– Preference for 5 years experience with Regulatory Affairs
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