Senior Regulatory Affairs Associate

🔥 12 hours 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

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

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 US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations) • Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL • Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications • Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead • Actively support regulatory compliance and ensure compliance of submissions to the US FDA • Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label. • Coordinate collection of functional documents in support of regulatory applications • Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes) • Assist the USRL in managing the process for responding to FDA questions • Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages) • Provide primary authorship to routine regulatory correspondence (e.g. annual reports) • Prepare regulatory packages and cross-reference letters to support investigator initiated studies • Complete regulatory forms to support agency communications (e.g. FDA form 1571) • 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 • Support the development and execution of GRT goals

🎯 Requirements

• Master’s degree • Or Bachelor’s degree and 2 years of regulatory or pharmaceutical experience • Or Associate’s degree and 6 years of regulatory or pharmaceutical experience • Or High school diploma / GED and 8 years of regulatory or pharmaceutical experience

🏖️ 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.