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Senior Regulatory Affairs Manager EU
Posted 4 days ago by 1751688477
£70 Per hour
Inside
Remote
Uxbridge
Summary: The EU Regulatory Affairs Manager role is a 12-month remote contract position within a prominent biotech company, focusing on regulatory submissions and strategy execution for clinical trials and marketing applications. The position requires collaboration with the Global Regulatory team and regional stakeholders to ensure compliance with local regulatory requirements. The role offers the potential for extension beyond the initial contract period.
Key Responsibilities:
- Support the creation of strategy and execution plans for regulatory submissions.
- Manage regulatory submissions for clinical trials and marketing applications.
- Advise the Global Regulatory team on regional considerations in strategy development.
- Ensure regional needs are well-defined and implemented in collaboration with stakeholders.
Key Skills:
- Prior experience with marketing authorizations (MAs), clinical trial applications (CTAs), and post-approval changes.
- Strong working knowledge of EU Clinical Trials Regulation (CTR).
Salary (Rate): £70 per hour
City: Uxbridge
Country: United Kingdom
Working Arrangements: remote
IR35 Status: inside IR35
Seniority Level: Mid-Level
Industry: Other
Your new company
This well-known biotech is looking for an experienced Regulatory Affairs Manager to join their established EU Regulatory Affairs team. This is a 12-month contract job with scope for extension.
This is a remote contract job with the need to go into the office once per month.
Your new role
As EU Senior Regulatory Affairs Manager, you will support the creation of strategy and execution plans and manage regulatory submissions (e.g., clinical trials and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.
As EU Senior Regulatory Affairs Manager, you will take the lead role in advising the Global Regulatory team on regional considerations in developing strategy, as well as ensuring the regional needs are well-defined and implemented in collaboration with relevant regional stakeholders.
What you'll need to succeed
In order to be considered for this contract job as EU Senior Regulatory Affairs Manager, you must have prior experience in the region of MAs, CTAs / post approval changes and amendments, extensions, and renewals. A strong working knowledge of EU CTR would be an advantage.
What you'll get in return
Remote working
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply to this advertisement.