Senior Associate Regulatory Affairs (Barcelona)

About the role

Amgen is hiring a Local Regulatory Representative (LRR), Senior Associate, in Barcelona. The role supports marketed products under the supervision of an experienced Local Regulatory Lead, working within the company's four therapeutic areas: Oncology, Inflammation, General Medicine and Rare Disease.

Key responsibilities

• Align local regulatory requirements with Amgen's corporate standards and provide national input to and execute regulatory strategies.
• Review promotional materials for compliance with regulatory requirements and company procedures.
• Plan and manage local regulatory submissions and ensure they are submitted on time.
• Create, review and approve source text for country labeling and own the country artwork based on that source text.
• Develop and maintain local labels in line with local legislation and Amgen standards, and act as the point of contact with regulatory agencies.
• Contribute to local regulatory process improvements, initiatives and training, and share regulatory intelligence with colleagues.
• Work with cross-functional colleagues in the Affiliate or Hub to deliver its goals.

Required profile

• Degree in Pharmacy, Biochemistry, Biotechnology, Biology or a related field; a Master's degree in the pharmaceutical industry is desirable.
• Fluency in Spanish and English; knowledge of Portuguese is a plus.
• Depth of knowledge of legislation and regulations relating to medicinal products.
• 2 or more years of relevant work experience in the pharmaceutical industry.

Required skills

• Ability to work in teams
• Attention to detail
• Strategic prioritization
• Solution-oriented problem solving

What we offer

• Vast opportunities to learn, develop and move up and across the global organization.
• A generous total rewards plan covering healthcare, finance, wealth and career benefits.
• Flexible work arrangements.