Senior Associate – Regulatory Affairs

🕒 6 days ago

🇺🇸 United States – Remote

💵 $84k - $113.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead • Assist U.S. Regulatory Lead to support regional regulatory activities • Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory Lead • Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications • Review regional component of the Global Regulatory Plan and provide input to operational deliverables • Ensure compliance with submissions to regulatory agencies • Support U.S. Regulatory Lead in review of HA interaction activities • Collaborate with CRO’s / partners to support site initiation, as applicable • Coordinate collection of functional documents in support of regulatory applications • As appropriate participate in GRT to support execution of regulatory strategy • Coordinate QC of regulatory documentation (e.g. briefing packages) • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) • Prepare regulatory packages and cross-reference letters to support investigator initiated studies • 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 through cross-functional interactions in brand and therapeutic area teams • Support process improvement initiatives, standards development, and metrics • Assist in template development and maintenance • Respond to specific requests from and communicate relevant issues to GRT • Develop Regulatory Position with teams • Actively support regulatory compliance • Support the development and execution of GRT goals

🎯 Requirements

• Master’s degree • Bachelor’s degree and 2 years of Regulatory Affairs experience • Associate’s degree and 6 years of Regulatory Affairs experience • High school diploma / GED and 8 years of Regulatory Affairs experience • Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum • Regulated industry, science or clinical practice experience • Timeline management • Strong communication skills - oral and written • Organizational skills • Ad hoc meeting support • Agendas, minutes

🏖️ 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.