CMC Regulatory Affairs Lead: Post-Market Strategy

Amgen Inc.; United States; Vor Ort; USD 150.000 - 185.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Discretionary annual bonus

Stock-based incentives

Award-winning time-off plans

Flexible work models

Zusammenfassung

Amgen seeks a Regulatory Affairs Manager - CMC to lead site-specific CMC post-market activities and regulatory filings. You will coordinate with site functions and CMC teams to assess issues, shape regulatory strategies, and ensure timely registrations.

The role requires strong regulatory experience, ICH/GMP knowledge, and the ability to interact with global teams. Amgen offers comprehensive benefits and a collaborative, science-driven culture.

Qualifikationen

• Doctorate degree required or equivalent regulatory affairs experience.
• Master's degree with 2+ years regulatory affairs experience.
• Bachelor's degree with 4+ years regulatory affairs experience.
• Associate's degree with 8+ years regulatory affairs experience.
• High school diploma with 10+ years regulatory affairs experience.

Aufgaben

• Define minimum regulatory filing requirements for post-approval programs.
• Provide regulatory strategy through development of MASP and/or GIRS.
• Develop post-approval variations.
• Maintain applications (Annual Reports, Distribution Reports, Annual Stability updates).
• Maintain product compliance through regulatory filings and commitments.
• Provide impact assessments for deviations with input from CMC teams.
• Support Change Management activities as needed.
• Respond to regulatory agency questions.
• Facilitate agency interactions and briefing documents.

Kenntnisse

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Attention to detail

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Jobbeschreibung

Amgen seeks a Regulatory Affairs Manager - CMC to lead site-specific CMC post-market activities and regulatory filings. You will coordinate with site functions and CMC teams to assess issues, shape regulatory strategies, and ensure timely registrations.

The role requires strong regulatory experience, ICH/GMP knowledge, and the ability to interact with global teams. Amgen offers comprehensive benefits and a collaborative, science-driven culture.