Senior Regulatory Policy and Intelligence Manager
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Job Description
Regulatory Manager at Amgen driving alignment on regulatory policies and engaging with external stakeholders. This role requires in-depth knowledge of legislation and strong communication skills.
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 helps manage projects for agreed upon policy objectives under the direction of and in partnership with policy lead(s) and management.
Requirements:
- Doctorate degree or 2 years of regulatory experience OR Master’s degree and 4 years of related experience OR Bachelor’s degree and 6 years of regulatory experience OR Associate’s degree and 10 years of regulatory experience OR High school diploma / GED and 12 years of regulatory experience
- 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.
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
- 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.
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