Senior Regulatory Affairs Manager EU

hays-gcj-v4-pd-online; Cambridge; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading biotech firm is seeking a Senior Regulatory Affairs Manager EU for a 12-month contract role based in Cambridge. The successful candidate will support strategy creation, manage regulatory submissions, and collaborate with the Global Regulatory team to ensure compliance with local requirements. Flexible working options are available for this vital role.

Benefits

Flexible working options

Qualifications

• Prior experience with regulatory submissions, including MAs and CTAs.
• Familiarity with post-approval changes and renewals.
• Ability to collaborate with regional stakeholders.

Responsibilities

• Support the creation of strategy and execution plans.
• Manage regulatory submissions for clinical trials and marketing applications.
• Advise the Global Regulatory team on regional regulatory requirements.

Job description

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Senior Regulatory Affairs Manager EU, Cambridge

Client:

Location:

Cambridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

Job Reference:

a2908739fbf7

Job Views:

7

Posted:

22.06.2025

Expiry Date:

06.08.2025

Job Description:

Senior Regulatory Affairs Manager EU - contract job
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 role
As Senior Regulatory Affairs Manager EU, you will support the creation of strategy and execution plans and manage regulatory submissions (clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.
You will also advise the Global Regulatory team on regional considerations, ensuring regional needs are well-defined and implemented in collaboration with relevant regional stakeholders.

Requirements
Prior experience in the region of MAs, CTAs, post-approval changes, amendments, extensions, and renewals is necessary.

Benefits
Flexible working options are available.