Overview

In this role you support marketed products under supervision, shaping regulatory strategies and ensuring compliant labeling and submissions. You will collaborate with cross-functional teams to align local requirements with corporate standards, manage timely regulatory submissions, and interact with agencies. The position offers growth in a global, inclusive environment with opportunities to influence local labeling and regulatory planning. This is a mission-driven role at Amgen, helping bring innovative medicines to patients.

Compensaciones / Beneficios

- Opportunity for learning and career development
- Diverse and inclusive environment
- Generous AMGEN Total Rewards Plan (healthcare, financial, retirement)
- Versátil work arrangements

Responsabilidades

- Align local regulatory requirements with Amgen’s corporate standards
- Contribute to and execute regulatory strategies at the national level
- Review promotional materials for regulatory compliance
- Serve as regulatory input in brand teams
- Plan and manage local regulatory submissions ensuring compliance
- Maintain local labels in line with legislation and standards




- Facilitate interactions with regulatory agencies
- Ensure timely regulatory submissions meeting corporate and local requirements
- Create, review, and approve country labeling text; own country artwork
- Act as point of contact with regulatory agencies for local obligations
- Participate in local agency interactions and preparation
- Collaborate with Affiliate/Hub cross-functionally to align strategy and goals
- Share regulatory information with cross-functional teams and advise on local regulations
- Contribute to local regulatory process improvements and training

Requisitos principales

- Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field
- 2+ years of relevant pharma industry experience
- Fluency in Spanish and English; Portuguese knowledge is a plus
- Deep knowledge of medicinal product legislation and regulations

- Teamwork
- Attention to detail
- Strategic prioritization
- Regulatory knowledge and submission management
- Labeling and artwork development
- Regulatory agency liaison and compliance

📌 LRR - Senior Associate Regulatory Affairs (Barcelona)
🏢 Amgen
📍 Barcelona