EU Regulatory Affairs Lead – Hybrid Work & Lifecycle Strategy

Amgen Inc. (IR); Uxbridge; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work flexibility

Total rewards package

Job summary

Amgen Inc. in the United Kingdom (Uxbridge/Cambridge hybrid) seeks an EU Regulatory Affairs Manager to lead submissions for clinical trials and marketed products.

You will craft regional regulatory strategies, provide guidance for regulatory documents, and ensure compliance with EU requirements across the product lifecycle. The role requires experience with regulatory procedures (scientific advice, orphan apps, PIP, MA) and strong communication.

Qualifications

• Degree-educated with experience in regulatory roles.
• Experience registering products and leading EU filings.
• Knowledge of EU legislation and regulatory policy.

Responsibilities

• Plan and manage regulatory submissions for clinical trials and marketing applications.
• Develop and execute regional regulatory product strategies.
• Provide regulatory guidance for regional documents and meetings.
• Monitor regulatory developments and assess impact on products.

Skills

Regulatory strategy

Regulatory submissions

EU regulatory knowledge

Communication skills

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

AI tools basic

Job description

Amgen Inc. in the United Kingdom (Uxbridge/Cambridge hybrid) seeks an EU Regulatory Affairs Manager to lead submissions for clinical trials and marketed products.

You will craft regional regulatory strategies, provide guidance for regulatory documents, and ensure compliance with EU requirements across the product lifecycle. The role requires experience with regulatory procedures (scientific advice, orphan apps, PIP, MA) and strong communication.