This role leads the development and articulation of regulatory policy positions impacting Amgen's business within a defined portfolio. Key responsibilities include managing U.S. trade association relationships, leading enterprise-wide regulatory reform initiatives, and developing advocacy materials. The position requires significant regulatory experience, with preferred qualifications including a scientific degree and in-depth knowledge of U.S. legislation and regulations for medicinal products.
Regulatory Policy and Intelligence Associate Director
What you will do
In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business within a defined portfolio, exercising independent judgement and driving cross-functional alignment. You will report to the Amgen’s U.S. Lead for Regulatory Policy and Intelligence.
Primary 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.
Additional Responsibilities:
- 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.
What we expect of you
Basic 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 Qualifications:
- 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 fact-paced environment with retaining a high attention to detail and quality.
- Excellent organization, process, and project management skills.
What you can expect of us
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $155,365 - $210,199. 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. Refer to the Work Location Type in the job posting to see if this applies.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
Salary Range
USD - USD