Senior Associate – Regulatory Affairs

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $84k - $113.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 the Regional Regulatory Lead with regional regulatory activities • Provide and maintain IND/MA documentation support, including annual reports and amendments • Create and maintain product regulatory history documents through RIM and archive regulatory documents and agency communications • Review regional components of the Global Regulatory Strategic Plan and provide input to operational deliverables • Conduct regulatory research supporting regulatory strategy and target product label development • Support regulatory compliance and submission compliance • Prepare supportive documentation for regulatory deliverables, including regulatory landscapes and research • Coordinate collection of functional documents for regulatory applications • Participate in GRT activities and assist with meeting management, agendas, and minutes • Assist with responses to regulatory agency questions • Coordinate quality control of regulatory documentation • Author routine regulatory correspondence, including annual reports and investigator packages • Prepare regulatory packages and cross-reference letters for investigator-initiated studies • Complete regulatory forms supporting agency communications, including FDA Form 1571 • Support process improvement initiatives, standards development, metrics, and template maintenance • Respond to GRT requests and communicate relevant issues • Support development and execution of GRT goals

🎯 Requirements

• Master’s degree; or Bachelor’s degree and 2 years of Regulatory Affairs experience; or Associate’s degree and 6 years of Regulatory Affairs experience; or high school diploma/GED and 8 years of Regulatory Affairs experience • Preferred: Bachelor’s degree in Life Sciences and 2–3 years of Regulatory Affairs experience • Experience setting up regulatory submissions • Ability to support regulatory activities, documentation, submissions, compliance, and agency communications • Ability to work in the United States (excluding Puerto Rico); sponsorship is not guaranteed

🏖️ 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, and flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance • Sponsorship for this role is not guaranteed