Senior Associate - Regulatory Affairs

Yesterday

Apply Now

Receive Emails with Similar Jobs

Amgen

WebsiteLinkedInAll Job Openings

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Assist in the creation and submission of regulatory documents • May be the regulatory lead for a program under supervision • Provide and maintain IND/BLA documentation support • Create and maintain product regulatory history documents • Review regional component of the Global Regulatory Plan • Ensure compliance with submissions to regulatory agencies • Collaborate with CRO’s / partners to support site initiation • Coordinate collection of functional documents in support of regulatory applications • Participate in GRT to support execution of regulatory strategy • Coordinate QC of regulatory documentation • Provide primary authorship to routine regulatory correspondence • Prepare regulatory packages and cross-reference letters • Approve drug shipment for Amgen and Investigator Initiated Studies • Complete regulatory forms to support agency communications • Provide regulatory support to Commercial, Medical and Clinical departments

🎯 Requirements

• Master’s degree • Or Bachelor’s degree & 2 years of Regulatory experience • Or Associates degree & 6 years of Regulatory experience • Or High school diploma / GED & 8 years of Regulatory experience • Regulated industry, science or clinical practice experience • Timeline management • Strong communication skills - oral and written • Organizational skills • Ad hoc meeting support

🏖️ Benefits

• 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 • Stock-based long-term incentives • Award-winning time-off plans and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements