Senior Local Regulatory Affairs Associate – Barcelona

Amgen SA; Bellprat; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Learning opportunities

Inclusive culture

Total rewards package

Flexible work arrangements

Job summary

Amgen SA is seeking a Local Regulatory Representative (LRR), Sr. Associate, to support marketed products under the supervision of a Local Regulatory Lead. The role focuses on aligning local regulatory requirements with Amgen standards and managing submissions.

You will review materials for regulatory compliance, provide regulatory input to brand teams, and collaborate with cross-functional colleagues to meet local obligations while advancing overall therapeutic goals.

Qualifications

• Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field
• Master’s degree on Pharmaceutical Industry desirable
• Fluency in Spanish and English languages. Knowledge of Portuguese would be a plus.
• Depth knowledge of legislation and regulations relating to medicinal products
• 2 or more years of relevant work experience within the pharmaceutical industry

Responsibilities

• Align local regulatory requirements with Amgen’s corporate standards.
• Provide national input to and execute regulatory strategies.
• Review promotional materials to ensure compliance with applicable regulatory requirements and company procedures.
• Serve as a member of brand teams, providing regulatory input and guidance.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.

Skills

Pharmacy degree

Biochemistry

English proficient

Spanish fluent

Teamwork

Education

Degree in Pharmacy or related field

Master’s degree in Pharmaceutical Industry desirable

Job description

Amgen SA is seeking a Local Regulatory Representative (LRR), Sr. Associate, to support marketed products under the supervision of a Local Regulatory Lead. The role focuses on aligning local regulatory requirements with Amgen standards and managing submissions.

You will review materials for regulatory compliance, provide regulatory input to brand teams, and collaborate with cross-functional colleagues to meet local obligations while advancing overall therapeutic goals.