Amgen seeks a Senior Associate in Regulatory Affairs to support marketed pharmaceutical products in Barcelona. The role involves managing local regulatory submissions, ensuring compliance with national and corporate standards, and serving as the primary contact with regulatory agencies.
Responsibilities
- Align local regulatory requirements with Amgen corporate standards and execute regulatory strategies
- Review promotional materials and manage local regulatory submissions for compliance
- Develop, maintain, and approve country-specific product labels and artwork
- Serve as primary contact with regulatory agencies and prepare for agency interactions
- Provide regulatory guidance to brand teams and cross-functional colleagues
Requirements
- Degree in Pharmacy, Biochemistry, Biotechnology, Biology, or related field
- Fluency in Spanish and English; Portuguese knowledge a plus
- Deep knowledge of medicinal product legislation and regulations
- 2+ years of relevant pharmaceutical industry experience
- Master's degree in Pharmaceutical Industry desirable
- Strong teamwork and attention to detail
- Strategic prioritization and solution-oriented problem-solving skills
Compensation: €40,943.65–€55,394.35 base
📌 LRR - Senior Associate Regulatory Affairs (Barcelona) (España)
🏢 Amgen
📍 España