Senior Associate – Regulatory Professional, Obesity and Related Conditions

🔥 0 minutes 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

• Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements • Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time • Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications • Create and maintain product regulatory history documentation, such as IMR, as applicable • Support U.S. labeling activities, including review of source text to enable U.S. labeling updates • Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements • Coordinate and QC briefing documents and other materials for meetings with regulatory agencies • Support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations • Support responses to health authority questions by coordinating inputs, tracking actions, and ensuring document readiness • Collate and communicate regulatory information across regulatory colleagues and cross-functional teams • Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; escalate and disseminate relevant updates • Participate in cross-functional and team governance, including GRT support such as agendas and minutes

🎯 Requirements

• Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum; OR bachelor’s degree in a science discipline and 2 years of directly related experience; OR associate’s degree in a science discipline and 6 years of directly related experience; OR high school diploma/GED in a science discipline and 8 years of directly related experience • Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare) • Experience supporting programs in Obesity, Diabetes, or related metabolic diseases through scientific or clinical work • Strong written and oral communication skills • Strong organizational skills; ability to manage multiple activities, timelines, and stakeholders • Demonstrated attention to detail and document quality mindset • Ability to identify, communicate, and escalate risks/issues appropriately • Experience with document management and archiving practices in a regulated setting

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support