EU Regulatory Affairs Manager - Flexible Work Options

Amgen Inc. (IR); Portugal; On-site; EUR 49,000 - 66,000; Full time

Benefits offered by this job

Flexible work arrangements

Total Rewards Plan

Job summary

AMGEN Capability Center Portugal, located in Lisbon, seeks an EU Regulatory Affairs Manager to ensure EU licenses for trials and products. Join a diverse, innovative team shaping healthcare through regulation and strategy in Europe.

The role involves planning regulatory submissions, guiding regional documents, and aligning with global strategies. Flexible work options and a strong rewards program accompany this opportunity.

Qualifications

• Degree educated with prior regulatory experience.
• Experience with registration procedures in the EU region (clinical trials, MA procedures, post-approval changes).
• Ability to develop regulatory strategies for products in development and post-marketing.

Responsibilities

• Plan and manage regulatory submissions for EU products in compliance with EU requirements.
• Implement product regulatory strategies and planning in line with EU regulations.
• Provide content guidance for regional regulatory documents and meetings.
• Advise on regulatory mechanisms to optimize development (e.g., scientific advice, paediatric plans).
• Support EU label negotiation activities and regional strategy development.
• Develop predictions for regulatory outcomes and risks under supervision.
• Stay updated on new EU regulatory guidance and legislation.

Skills

Regulatory experience

EU regulatory submissions

Regulatory strategies

EU legislation knowledge

Communication skills

AI tools awareness

Education

Degree educated

Job description

AMGEN Capability Center Portugal, located in Lisbon, seeks an EU Regulatory Affairs Manager to ensure EU licenses for trials and products. Join a diverse, innovative team shaping healthcare through regulation and strategy in Europe.

The role involves planning regulatory submissions, guiding regional documents, and aligning with global strategies. Flexible work options and a strong rewards program accompany this opportunity.