Global Regulatory Affairs Director – Inflammation and Rare Disease

🕒 Julho 22

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $189.632 - $256.561 / ano

⏰ Tempo Integral

🔴 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 and execute the global regulatory product strategy • Lead GRTs • Represent Regulatory on the product team and other key commercialization governance bodies • Develop Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. • Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. • Identify and communicate regulatory risks • Represent GRA on the product team • Develop registration strategies and plans aimed at achieving regulatory approval and product labeling • Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent • Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents) • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment • Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy • Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood • Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams) • Attend key regulatory agency meetings which could impact the global product strategy • Represent Amgen Regulatory on external partnership teams at the product level.

🎯 Requisitos

• Doctorate degree and 4 years of regulatory experience in biotech or science • Or Master’s degree and 7 years of regulatory experience in biotech or science • Or Bachelor’s degree and 9 years of regulatory experience in biotech or science • Ability to lead and build effective teams • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against future strategic issues & uncertainties • Ability to resolve conflicts and develop a course of action • Cultural awareness and sensitivity to achieve global results • Planning and organizing abilities • Able to prioritize and manage multiple activities • Ability to make complex decisions and solve problems • Ability to deal with ambiguity • Negotiation skills.

🏖️ Benefícios

• 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.