Global Regulatory Submission Planning Sr. Manager – Obesity

🕒 il y a 22 jours

🇺🇸 États-Unis – Télétravail

💵 $142 579 - $192 901 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• Serve as the regulatory product planning lead for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications. • Develop and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business priorities. • Partner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategies. • Establish and maintain visibility into critical regulatory milestones, ensuring leadership has a clear understanding of readiness, risks, dependencies, and potential impacts to regulatory objectives. • Facilitate regulatory planning forums to support decision-making, issue resolution, and proactive management of emerging regulatory challenges.

🎯 Exigences

• Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience • a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • Experience supporting global regulatory activities within obesity, cardiometabolic, or related therapeutic areas. • Strong understanding of global drug development and regulatory processes, including major regulatory milestones, health authority interactions, and submission requirements across key regions. • Demonstrated understanding of end-to-end product development and commercialization processes and the interdependencies that influence regulatory execution. • Experience developing and maintaining integrated plans within complex, matrixed organizations. • Demonstrated ability to coordinate and align activities across multiple indications, functions, regions, and stakeholders. • Excellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environment.

🏖️ Avantages

• 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.