Senior Regulatory Affairs Manager EU

TN United Kingdom; Uxbridge; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading biotech company is seeking an experienced Senior Regulatory Affairs Manager for a 12-month remote contract position based in Uxbridge. The role involves managing regulatory submissions and collaborating with regional stakeholders to ensure compliance with local requirements. This position offers the flexibility of remote work with occasional office visits.

Benefits

Remote working opportunity

Qualifications

• Prior experience in MAs, CTAs, post-approval changes, amendments, extensions, and renewals required.
• Strong working knowledge of EU CTR is an advantage.

Responsibilities

• Support creation of strategy and execution plans for regulatory submissions.
• Advise Global Regulatory team on regional considerations.

Skills

Regulatory Affairs

Compliance

Strategy Development

Job description

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Senior Regulatory Affairs Manager EU, Uxbridge

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Client:

Location:

Uxbridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

ce822415dc16

Job Views:

3

Posted:

17.05.2025

Expiry Date:

01.07.2025

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Job Description:

EU Regulatory Affairs Manager - contract job

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 with scope for extension. It is a remote contract with the need to go into the office once per month.

Your new role

As a Global Regulatory Affairs Manager, you will support the creation of strategy and execution plans, and manage regulatory submissions (clinical trial and marketing applications) for products within the portfolio, ensuring compliance with global filing plans and local regulatory requirements.

You will take the lead in advising the Global Regulatory team on regional considerations in developing strategy, and ensure regional needs are well-defined and implemented in collaboration with relevant regional stakeholders.

What you'll need to succeed

Prior experience in the region of MAs, CTAs, post-approval changes, amendments, extensions, and renewals is required. A strong working knowledge of EU CTR would be an advantage.

What you'll get in return

Remote working opportunity.