Senior Regulatory Affairs, Barcelona — Flexible Work

Amgen; España; On-site; EUR 41,000 - 55,000; Full time

Benefits offered by this job

Generous Total Rewards Plan

Flexible work arrangements

Job summary

Amgen in Spain seeks a Local Regulatory Representative (LRR), Sr. Associate to align local regulatory requirements with corporate standards and to drive regulatory submissions across affiliates.

You will review promotional materials, interact with regulatory agencies, and collaborate with brand teams to ensure compliance and timely product approvals. Fluency in Spanish and English is required, Portuguese is a plus.

Qualifications

• Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field.
• Master's degree in 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

• Assist in aligning 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.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Enable regulatory agencies interactions.
• Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.
• Create, review, and approve source text for country labeling, and own the country artwork based on source text.
• Act as the point of contact with regulatory agencies in fulfilling local obligations.
• Participate/contribute to local agency interactions and their preparation.
• Work closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
• Participate in local regulatory process improvements, initiatives and training.

Skills

Spanish language

English language

Regulatory knowledge

Education

Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field

Master's degree in Pharmaceutical Industry desirable

Job description

Amgen in Spain seeks a Local Regulatory Representative (LRR), Sr. Associate to align local regulatory requirements with corporate standards and to drive regulatory submissions across affiliates.

You will review promotional materials, interact with regulatory agencies, and collaborate with brand teams to ensure compliance and timely product approvals. Fluency in Spanish and English is required, Portuguese is a plus.