Regulatory Policy and Intelligence Associate Director

Amgen•Washington, DC

1d•$155,365 - $210,199

About The Position

The Regulatory Policy and Intelligence Associate Director leads the development and articulation of Amgen’s positions on regulatory policies affecting its business within a defined portfolio. The role exercises independent judgment and drives cross-functional alignment. The Regulatory Policy and Intelligence team advances policy issues aligned with Amgen’s goals by engaging with regulators, trade associations, consortia, other stakeholders, and internal subject matter experts. The position reports to Amgen’s U.S. Lead for Regulatory Policy and Intelligence. The role stewards U.S. trade association relationships and company engagements related to regulation and R&D, supports executives serving in domestic and international forums, and leads enterprise-wide regulatory reform initiatives. It also develops and implements strategies to shape policy outcomes and the external environment, identifies internal business needs for implementation, and leads assigned policy initiatives from analysis and position development through external engagement and implementation. The Associate Director works with policy leads and subject matter experts across Government Affairs, R&D, Operations, and other areas to develop advocacy materials, support alignment on positions and strategies, research policy questions, assess emerging regulatory developments, analyze regulatory guidance and policy documents, and plan and manage projects tied to policy objectives.

Requirements

Doctorate degree or 3 years of regulatory experience; or a master’s degree and 5 years of related experience; or a bachelor’s degree and 7 years of regulatory experience; or an associate’s degree and 12 years of regulatory experience; or a high school diploma/GED and 14 years of regulatory experience.

Nice To Haves

Doctorate or master’s degree in a scientific area and 10 years of directly related regulatory policy experience, including experience with FDA and international regulators.
Bachelor’s degree in a scientific area and 12 years of directly related experience.
In-depth knowledge and demonstrated policy leadership with U.S. legislation and regulations relating to medicinal products.
Trade association or consortia experience.
Strong teamwork and a demonstrated track record of collaboration across functional areas.
Strong oral and written communication skills.
Strong interpersonal, problem-solving, and conflict-resolution skills.
Ability to work well with people at all organizational levels in demanding situations, with a positive attitude, tact, diplomacy, and respect.
Ability to work in a fast-paced environment while maintaining high attention to detail and quality.
Excellent organization, process, and project management skills.

Responsibilities

Foster U.S. trade association relationships and provide stewardship over the company’s regulatory and R&D-related trade association engagements.
Staff company executives in leadership roles in domestic and international forums.
Develop and lead enterprise-wide regulatory reform initiatives; implement strategies to shape policy outcomes and the external environment, and identify related internal business needs for implementation.
Lead assigned policy initiatives from analysis and position development through external engagement and implementation, in partnership with policy leads and management.
Partner with policy leads and subject matter experts, including Government Affairs, R&D, Operations, and other relevant stakeholders, to develop advocacy materials on priority policy issues.
Prepare presentations and other communications to support alignment on positions and strategies across Amgen organizations and regions.
Investigate policy research questions on key policy topics and determine the implications of emerging regulatory developments.
Analyze regulatory guidances and other regulatory policy documents to inform positions and impact assessments.
Plan and help manage projects for agreed policy objectives under the direction of and in partnership with policy leads and management.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.