Regulatory Affairs Senior Associate

If you feel like you are part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Regulatory Affairs Senior Associate

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What you will do

The Local Regulatory Sr. Associate is assigned to one or more Amgen products and supports all local regulatory activities.

• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national input to regulatory strategies.
• 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.
• Act as the point of contact with regulatory agencies.

Strategic and Execution

• Ensures local regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Reviews and approves source text for country labeling and owns the country artwork based on source text.
• Reviews the promotional materials.
• Participates in the regulatory submission of Direct Healthcare Professional Communications (DHPCs) & additional Risk Minimization Measures (aRMMs).
• Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

Health Authority Interactions

• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation.

Communication and Collaboration

• Works closely with cross-functional colleagues in the affiliate to align on strategy and deliver affiliate goals.
• Exchanges 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.
• Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of assigned Amgen molecules.
• Partners with peers to ensure consistency on procedures.
• Acts as contact and create relationships with Agency staff on specific product assignment.
• Provide SME support to process improvement projects / initiatives.

Country Specific Activities

• Participates in local regulatory process improvements, initiatives and training.
• Assists locally in Healthcare Compliance activities.

Regulatory Research

• Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The industrial engineer we seek is an analytical person with these qualifications:

Scientific and Technical

• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• Understanding of drug development.
• Demonstrate ability to work in teams.
• Good communication skills – both oral and written.
• Ability to understand and communicate scientific/clinical information

Education & Experience

• Master’s degree (scientific area) OR
• Bachelor’s degree (scientific area) and 2 years of directly related experience.
• In-depth regulatory experience related to EU/the Netherlands including the review of promotional materials
• In-depth knowledge of EU/Dutch legislation and regulations relating to medicinal products including on the local code of conduct on pharmaceutical advertising (CGR)

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance, and collective health insurance.
• Focus on vitality with an on-site gym, a vitality program, and a restaurant with healthy food.
• Flexible work arrangement with 3 - 4 days a week in the office and days from home.