Director, Regulatory Policy & Intelligence

Regulatory Jobs; United States; Remote; USD 155,000 - 210,000; Full time

Job summary

Amgen is seeking a Regulatory Policy and Intelligence Associate Director to lead policy positions within a defined portfolio, collaborating with regulators, trade associations, and internal experts. You will drive cross-functional alignment and shape regulatory outcomes to advance Amgen's mission to serve patients.

You will manage enterprise-wide reform initiatives, staff executives in forums, and develop advocacy materials while reporting to the U.S. Lead for Regulatory Policy and Intelligence.

Qualifications

• Doctorate degree or 3 years of regulatory experience
• OR Master’s degree and 5 years of related experience
• OR Bachelor’s degree and 7 years of regulatory experience
• OR Associate’s degree and 12 years of regulatory experience
• OR High school diploma / GED and 14 years of regulatory experience
• Preferred: Doctorate or Master’s degree (scientific area) and 10 years of directly related regulatory policy experience, including FDA and international regulators
• Bachelor’s 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 organizing in demanding situations with a positive attitude, tact, diplomacy, and respect
• Demonstrated ability to work in a fast-paced environment with retaining a 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, 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

Skills

Strong oral and written communication

Strong interpersonal

Problem solving

Conflict resolution

Team player

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a Regulatory Policy and Intelligence Associate Director to lead policy positions within a defined portfolio, collaborating with regulators, trade associations, and internal experts. You will drive cross-functional alignment and shape regulatory outcomes to advance Amgen's mission to serve patients.

You will manage enterprise-wide reform initiatives, staff executives in forums, and develop advocacy materials while reporting to the U.S. Lead for Regulatory Policy and Intelligence.