Regulatory Policy & Intelligence Leader

BioSpace; Washington (District of Columbia); On-site; USD 155,000 - 210,000; Full time

Job summary

Amgen in the United States is seeking a Regulatory Policy and Intelligence Associate Director to lead the development and articulation of regulatory positions, coordinating with internal experts and external regulators across a defined portfolio.

You will foster trade association relationships, staff executives in leadership forums, guide policy reform initiatives, and manage cross‑functional projects. The role offers a competitive salary range of $155,365 to $210,199 per year.

Qualifications

• Doctorate degree or 3 years of regulatory experience.
• Masters degree and 5 years of related experience.
• Bachelor's degree and 7 years of regulatory experience.
• Associates degree and 12 years of regulatory experience.
• High school diploma / GED and 14 years of regulatory experience.
• Preferred: Doctorate or Masters degree (scientific area) and 10 years of directly related regulatory policy experience, including FDA and international regulators.
• Preferred: Bachelors degree (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.
• 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 capacity to work well with people at all levels of the organization in demanding situations with a positive attitude, tact, diplomacy, and respect.
• Excellent organization, process, and project management skills.

Responsibilities

• Foster U.S. trade association relationships and oversee 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, 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 the 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 upon policy objectives under the direction of and in partnership with policy lead(s) and management.

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma / GED

Job description

Amgen in the United States is seeking a Regulatory Policy and Intelligence Associate Director to lead the development and articulation of regulatory positions, coordinating with internal experts and external regulators across a defined portfolio.

You will foster trade association relationships, staff executives in leadership forums, guide policy reform initiatives, and manage cross‑functional projects. The role offers a competitive salary range of $155,365 to $210,199 per year.