Senior Regulatory Affairs Manager

🕒 il y a 20 jours

🌪️ Kansas – Distant

🌪️ Kansas – Remote

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Argenta

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2006

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €30 000 000 Private Equity Round en 2021-05

Biotechnology • Pharmaceuticals • Science

Argenta est une organisation mondiale de recherche sous contrat, de développement et de fabrication (CRO/CDMO) dédiée exclusivement à la santé animale. Ils offrent des services complets allant du développement de médicaments aux services réglementaires et cliniques, jusqu'à la fabrication, en employant une approche 'de la molécule au marché'. Argenta collabore avec des entreprises du monde entier pour développer et mettre sur le marché des produits pharmaceutiques et de santé animale. Leur expertise inclut les conseils réglementaires, les études cliniques et le soutien à la fabrication, livrant chaque année plus d'un milliard de doses de médicaments pour la santé animale. Avec une grande équipe de scientifiques, de vétérinaires et de consultants et plusieurs sites de fabrication approuvés par l'EMA et la FDA, Argenta se consacre à l'avancement de la santé animale par l'innovation, y compris le développement de nouvelles thérapies comme les anticorps monoclonaux et les cellules souches.

Description

• Facilitates and supports the regulatory and drug development requirements of external clients and internal projects • Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications • Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges • Creates regulatory solutions to complex issues • Provides client accurate expert regulatory advice on animal health product development • Represent Argenta in industry associations (e.g. GADA, AHI, SQA) • Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications

🎯 Exigences

• Bachelor’s degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred • 8+ years experience in veterinary regulatory and/or animal drug development • Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA • Development and regulatory experience with food animal drugs is preferred but not required • Good written and oral communication skills, and ability to work collaboratively within and across teams • Results and bottom line oriented • Excellent analytical skills and attention to detail • Proven influence, negotiation and persuasion skills • Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs • This position is subject to a DEA background check post offer and at regular intervals • This position is also required to complete a post offer drug test. Both the background and drug test must comply with company standards or offers of employment will be rescinded.

🏖️ Avantages

• Remote position • Domestic and occasionally international travel flexibility