US Regulatory Lead
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Job Description
US Regulatory Lead providing regulatory expertise for Amgen molecules. Planning and executing regulatory strategies in compliance with local regulations.
Responsibilities:
- Join Amgen’s Mission of Serving Patients.
- Provide local input to and execute regulatory strategies.
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Manage the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements.
- Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
Requirements:
- Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience
- Knowledge of Regulatory principles.
- In-depth regulatory experience in the applicable country(ies).
- In-depth knowledge of country(ies) legislation and regulations relating to medicinal products.
- Working with policies, procedures, and SOP’s.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- General knowledge of national legislation and regulations relating to medicinal products.
- General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
- Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
- Understanding of drug development.
- Good communication skills - both oral and written.
- Good negotiation and Influencing skills.
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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