Regulatory Strategy and Submissions Manager

3 weeks ago


Buckinghamshire, United Kingdom Cpl Full time

Job Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)

Job Type: 12-month contract 

Location: Berkshire, UK â Hybrid 

Pay Rate: £65-75 per hour (PAYE)


We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. You will work as a Regulatory EU CTR SME and support several EU CTR submissions. 


As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submission-related aspects of clinical trials. You will serve as the main point of contact and be responsible for delivering submission-specific milestones while offering guidance on submission strategies. Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments. Your role may also involve serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions.


Responsibilities:

⢠Lead/support all CTR initial submissions, transitions, amendments, and re-submissions

⢠Prepare all CTR-related documentation and be responsible for uploading this to the CTIS portal

⢠Work as an SME for the CTIS portal advising on how to use this system

⢠Participate in EU-CTR consulting and contribute to its operational implementation

⢠Drive EU CTR submissions, amendments, and strategies

⢠Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials

⢠Offer guidance on submissions expertise to junior team members

⢠Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials


Skills and Experience required:

⢠University degree in a scientific discipline

⢠Background in clinical trial management

⢠Experience in Regulatory Affairs

⢠Good level of knowledge of Clinical Trial Submissions on a local and regional level

⢠Working knowledge of submissions under EU-CTR directive

⢠Solution-oriented and problem-solving skills

⢠Customer-oriented and able to work in a team as well as autonomously

⢠Fluency in English is a must (written and spoken), along with proficiency in the local language


You must be able to be based on site 3x a week in Berkshire, UK, and have the FULL right to work in the UK. For more information or to apply please reach out to lucy.kirkaldy@cpl.com



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