Reference Number: JO-2401-527947
Regulatory Clinical Strategy & Submissions Manager
Job Type: Contract
Regulatory Clinical Trial Strategy & Submissions Manager
12 month contract
Berkshire based – Hybrid working
Offering up to £45.00 Per Hour via PAYE
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. The preferred candidate with have a background with EU CTR experience.
Job Responsibilities include;
– 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
Candidate Requirements include;
– Eligible to live and work in the United Kingdom
– Life Sciences degree or equivalent qualification
– Must be able to commit to commuting Berkshire office twice per week
– Must have previous experience with EU CTR or CTIS
– Preference for 5 years experience with Regulatory Affairs
If this opportunity if of interest please email your up to date CV to email@example.com.