Regulatory Affairs Manager – CMC

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $112.7k - $152.5k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 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

• Develop strategy and execute site-specific aspects of CMC post-market supplements and facility registrations • Interface with site functions to coordinate preparation of regulatory filings • Identify issues and factors that may implicate regulatory strategy or activity • Provide impact assessments for deviations with input from CMC Product teams and the CMC Region representative • Define minimum regulatory filing requirements for post-approval programs • Provide regulatory strategy through development of MASP and/or GIRS • Develop post-approval variations • Maintain applications, including Annual Reports, Distribution Reports, and Annual Stability updates • Maintain product compliance through regulatory filings, activities, and regulatory commitments • Support Change Management activities • Respond to regulatory agency questions • Facilitate agency interactions, including meeting preparation, meetings, and briefing documents • Liaise with development, operations, and commercial functions to align global regulatory strategies, timing, execution, and plans • Contribute to the PDT’s Variation Master Plan • Participate as an active member of cross-functional teams

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of Regulatory Affairs experience OR Bachelor’s degree and 4 years of Regulatory Affairs experience OR Associate’s degree and 8 years of Regulatory Affairs experience OR High school diploma / GED and 10 years of Regulatory Affairs experience • Degree in a life sciences discipline, or equivalent relevant experience • Experience in Regulatory CMC within the pharmaceutical or biotechnology industry • Working knowledge of ICH guidelines and current GMP and GCP requirements • Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure • Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA) • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Financial plans with opportunities to save towards retirement or other goals • Career development opportunities • Reasonable accommodation for individuals with disabilities

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