Regulatory CMC Manager: Post‑Market Strategy

Amgen Inc.; Thousand Oaks (CA); Ibrido; USD 113.000 - 153.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive benefits package

Bonus program

Stock-based incentives

Time-off plans

Flexible work models

Descrizione del lavoro

Amgen is seeking a Regulatory Affairs Manager - CMC to lead strategy and execution for site-specific CMC post-market filings and facility registrations. You will coordinate regulatory filings, identify issues impacting regulatory strategy, and provide impact assessments with cross-functional input.

The role requires advanced regulatory expertise (CMC, ICH, GMP/GCP) and experience preparing CTD-style dossiers, with opportunities to interact with global agencies and cross-functional teams.

Competenze

• Doctorate or 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 / GED with 10 years Regulatory Affairs experience.

Mansioni

• Define minimum regulatory filing requirements for post-approval programs.
• Develop regulatory strategy through MASP and/or GIRS.
• Develop post-approval variations and maintain applications.
• Ensure product compliance through regulatory filings and activities.

Conoscenze

Regulatory strategy

ICH guidelines

CMC knowledge

Regulatory submissions

Formazione

Doctorate or Master’s with 2+ yrs Regulatory Affairs

Bachelor’s with 4 yrs Regulatory Affairs

Associate’s with 8 yrs Regulatory Affairs

High school diploma with 10 yrs Regulatory Affairs

Descrizione del lavoro

Amgen is seeking a Regulatory Affairs Manager - CMC to lead strategy and execution for site-specific CMC post-market filings and facility registrations. You will coordinate regulatory filings, identify issues impacting regulatory strategy, and provide impact assessments with cross-functional input.

The role requires advanced regulatory expertise (CMC, ICH, GMP/GCP) and experience preparing CTD-style dossiers, with opportunities to interact with global agencies and cross-functional teams.