Sr Associate GRAAS Operations

Let’s do this. Let’s change the world. In this vital role, you will join a team that interacts with Global Regulatory Affairs and Strategy (GRAAS) and CMC to communicate and advance processes in alignment with Amgen’s company goals and objectives. The role involves day-to-day administrative responsibilities onsite and leading and supporting several project initiatives as needed.

Responsibilities

• Manage the complete US FDA Certificate of Pharmaceutical Product (CPP) process — from application drafting and submission to Health Authorities through delivery to international destinations.
• Serve as the primary liaison between FDA and internal requestors for issue resolution and coordination of updates to ensure timely communication and document modifications.
• Initiate and manage the authentication process for CPPs by the US State Department, Embassies, and Chambers of Commerce, to final dispatch to international destinations.
• Track and manage CPP applications through various stages of process lifecycle.
• Support the State Licensing team by routinely monitoring the ATO physical mailbox, scanning documentation, and coordinating shipment of hard-copy materials via U.S. Mail and courier services
• Manage the authentication process for country-specific documents across products, modalities, sites, and phases of development
• Obtain required document authentications and coordinate timely dispatch to appropriate end users (e.g., health authorities, local regulatory representatives, Amgen partners)
• Archive documents in accordance with established procedures and regulatory requirements
• Maintain authentication process documentation and provide training to CMC staff on authentication workflows and requirements
• Work onsite 1–2 days per week to coordinate notarization and obtain signatures as needed to meet regulatory timelines
• Assist Regulatory teams with managing CMC Compendial Monographs from European Pharmacopeia (Ph.Eur), US Pharmacopeia (USP), and Japanese Pharmacopeia (JP).
• Provide analytical support and follow-up for special projects and initiatives, including issue resolution related to invoicing and document management.
• Leverage digital tools (e.g., Smartsheet or similar platforms) to automate workflows, track deliverables, and maintain accurate documentation.
• Maintain shared resources and documentation on SharePoint and Microsoft Teams.
• Check and provide FDA Forms (1571 and 365h) to USRLs/RPs/CMC as needed.
• Anticipate challenges and resolve issues proactively using sound judgment and diplomacy.

Basic Education and Experience:

• Master’s degree

OR

• Bachelor’s degree and 2 years of directly related experience

OR

• High school diploma / GED and 8 years of directly related experience

Preferred Experience

• Proven experience coordinating with cross-functional teams and driving process improvements.
• Strong organizational skills and attention to detail.
• Excellent verbal and written communication skills.
• Expert knowledge of Veeva Vault RIM.
• High level of digital literacy with a variety of tools (e.g. Smartsheet, Miro, MS Copilot, ChatGPT Enterprise, Tableau) with a willingness to learn and adapt to new tools.
• Ability to handle multiple tasks and deadlines in a fast-paced environment.
• Strong interpersonal skills with the ability to influence and engage stakeholders at all levels.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.