Regulatory Policy and Intelligence Senior Manager

Amgen • Thousand Oaks, CA

1d

About The Position

The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, and patient advocates, along with internal subject matter experts across Amgen. In this vital role you will support the development, articulation, and implementation of Amgen's positions on regulatory policies that impact Amgen's business and will report to the Amgen’s U.S. Lead for Global Regulatory Policy and Intelligence.

Requirements

• Doctorate degree or 2 years of regulatory experience
• Master’s degree and 4 years of related experience
• Bachelor’s degree and 6 years of regulatory experience
• Associate’s degree and 10 years of regulatory experience
• High school diploma / GED and 12 years of regulatory experience

Nice To Haves

• Doctorate or Master’s degree (scientific area) and 6 years of directly related regulatory policy experience, including knowledge of FDA or EMA, or international regulators.
• Bachelor’s degree (scientific area) and 8 years of directly related experience
• In-depth regulatory experience in the U.S.
• In-depth knowledge of U.S. legislation and regulations relating to medicinal products.
• A strong team player with a demonstrated track record of working collaboratively across functional areas.
• Strong oral and written communication skills.
• Strong interpersonal, problem solving, and conflict resolution skills.
• Demonstrated ability to work well with people at all levels of an organization in demanding situations with a positive attitude, tact, diplomacy, and respect.
• Demonstrated ability to work in a fast-paced environment while retaining a high attention to detail and quality.
• Excellent organizational, process and project management skills.
• Strong computer skills including experience with MS Office, Smartsheet, and SharePoint.

Responsibilities

• Promotes internal awareness of key regulatory policy activities, including International Council for Harmonization (ICH) activities; drives and coordinates alignment and implementation considerations across Amgen functions.
• Prepares presentations and other communications to support alignment on positions and strategies across Amgen functions and regions.
• Investigates policy research questions on key policy topics and determines the implications of emerging draft and final regulations and guidance documents.
• Analyzes regulatory guidances and other regulatory policy documents to inform positions and impact assessments.
• Supports global commenting process on health authority consultations with input from stakeholders.
• Plans and help manages projects for agreed upon policy objectives under the direction of in partnership with policy lead(s) and management.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees