EU Regulatory Affairs Manager | Flexible Work

Amgen SA; Lisboa; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

AMGEN Capability Center Portugal in Lisbon seeks an experienced EU Regulatory Affairs Manager to ensure regulatory submissions and strategies across the EU region. You will support one or more products from an EU regulatory perspective within Amgen’s Europe operations.

The role involves collaboration with Global Regulatory Affairs teams, exposure to clinical trials, MA procedures, and regional regulatory processes. Excellent knowledge of EU legislation and strong communication are essential.

Qualifications

• Degree educated and previous experience in a similar role.
• Hands-on experience with registration procedures in the region (clinical trials, MA procedures, PAIPs, etc.).
• Experience developing regulatory strategies for products in clinical development and post-marketing phases.
• Knowledge of EU legislation and regulations relating to medicinal products.
• Strong communications skills - oral and written.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action.
• Basic proficiency in using AI tools to support day-to-day work.

Responsibilities

• Plan and manage regulatory submissions for products within Amgen's portfolio.
• Provide regulatory guidance on regional documents and meetings.
• Support EU label negotiation activities.
• Develop regional regulatory product strategies under supervision.
• Maintain awareness of new EU regulations and guidance.

Skills

Degree educated

EU registration procedures

Regulatory strategies

EU legislation knowledge

Strong communication

Anticipation of issues

Conflict resolution

AI tools for work

Education

Bachelor's degree in Life Sciences or related field

Job description

AMGEN Capability Center Portugal in Lisbon seeks an experienced EU Regulatory Affairs Manager to ensure regulatory submissions and strategies across the EU region. You will support one or more products from an EU regulatory perspective within Amgen’s Europe operations.

The role involves collaboration with Global Regulatory Affairs teams, exposure to clinical trials, MA procedures, and regional regulatory processes. Excellent knowledge of EU legislation and strong communication are essential.