Regulatory Affairs Manager – CMC

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $112.744 - $152.536 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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