Overview

Reference Number: JO-2401-527947
Regulatory Clinical Strategy & Submissions Manager
Rate: Negotiable
Job Type: Contract
Location: Maidenhead

Regulatory Clinical Trial Strategy & Submissions Manager

12 month contract

Berkshire based – Hybrid working 

Offering up to £45.00 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. 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 sophie.malyon@cpl.com.

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