Regulatory Affairs Manager Oncology

Hays; Uxbridge; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An established industry player in the biopharmaceutical sector is seeking a Regulatory Affairs Manager to join their oncology team. This 12-month hybrid contract role offers the chance to work closely with the EU Regulatory Lead, focusing on the operational and procedural aspects of regulatory submissions. You will play a key role in preparing Marketing Authorisation Applications and managing Life Cycle Management for European Centralised Procedures. The position provides flexible working options and a competitive hourly rate, making it an exciting opportunity for experienced professionals looking to make a significant impact in the field of regulatory affairs.

Benefits

Flexible working options

Good hourly rate

Discretionary bonus

Qualifications

• Experience in Regulatory Affairs with knowledge of EU regulations.
• Direct experience with EMEA submissions and clinical background.

Responsibilities

• Manage operational aspects of regulatory submissions in the EU.
• Support preparation and filings for new Marketing Authorisation Applications.

Skills

Regulatory Affairs

EU Regulations

Clinical Experience

Job description

Regulatory Affairs Manager, EU, Oncology

Contract Job, Hybrid

Your new company

This global biopharmaceutical company is looking for an experienced Regulatory Affairs professional to join them on a contract basis. A 12-month, hybrid contract job with scope for extension.

Your new role

As Regulatory Affairs Manager, you will work closely with the EU Regulatory Lead within the oncology team, managing the operational and procedural aspects and providing support for new Marketing Authorisation Applications’ preparation and filings as well as Life Cycle Management for the European Centralised Procedures.

In this role, you will plan and track activities related to regulatory submissions in the EU, communicate regulatory submission dates, regulatory status, nature of changes, and track and inform relevant parties of minor/significant product information changes.

What you'll need to succeed

Previous experience working in Regulatory Affairs and a strong working knowledge of EU regulations are essential. All applicants must have worked directly with EMEA on different types of submissions and have clinical experience.

What you'll get in return

Flexible working options, a good hourly rate, and a discretionary bonus.

What you need to do now

For more information on this or any other contract jobs in Regulatory Affairs, please apply to this job advert.