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Senior Regulatory Affairs Manager EU
Posted 4 days ago by 1749572697
£70 Per hour
Inside
Undetermined
Cambridge
Summary: The Senior Regulatory Affairs Manager EU will play a pivotal role in the established EU Regulatory Affairs team of a prominent biotech company. This 12-month contract position involves developing regulatory strategies and managing submissions for clinical trials and marketing applications. The role requires collaboration with the Global Regulatory team to ensure regional needs are met. Candidates must have relevant experience in managing marketing authorizations and clinical trial applications.
Key Responsibilities:
- Support the creation of regulatory strategy and execution plans.
- Manage regulatory submissions for clinical trials and marketing applications.
- Advise the Global Regulatory team on regional considerations.
- Ensure regional needs are defined and implemented with stakeholders.
Key Skills:
- Prior experience in marketing authorizations (MAs) and clinical trial applications (CTAs).
- Knowledge of post-approval changes, amendments, extensions, and renewals.
- Strong collaboration and communication skills.
Salary (Rate): £70 per hour
City: Cambridge
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: inside IR35
Seniority Level: Senior
Industry: Other
Your new company
This well-known biotech is looking for an experienced Senior Regulatory Affairs Manager to join their established EU Regulatory Affairs team. This is a 12-month contract job with scope for extension.
Your new role
As Senior Regulatory Affairs Manager EU, you will support the creation of strategy and execution plans and manage regulatory submissions (e.g., clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.
As 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 Senior Regulatory Affairs Manager EU, you must have prior experience in the region of MAs, CTAs / post approval changes and amendments, extensions, and renewals.
What you'll get in return
Flexible working options are available.
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply to this advertisement.