Sr Associate GRAAS Operations

Amgen•Thousand Oaks, CA

12d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

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.

Benefits

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.