Senior FIFRA Regulatory Affairs Manager

Emploi pas sur LinkedIn

🕒 il y a 2 jours

🔔 Pennsylvania – Distant

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⏱ Temps Partiel

🟠 Senior

🚔 Conformité

👻 Score fantôme 16%

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🗣️🇺🇸🇬🇧 Anglais requis

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knoell

501 - 1000 employés

Fondée en 1996

💼 Conseil

🏥 Santé

🍽️ Alimentation et boissons

Consulting • Healthcare • Food & Beverage

knoell est un cabinet de conseil international en réglementation et en sciences qui aide les entreprises à obtenir et à maintenir la commercialisation de produits chimiques, de produits de protection des cultures, de biocontrôles, de nutrition des cultures, de biocides, de dispositifs médicaux, de produits de santé animale, de matériaux au contact des aliments, de cosmétiques et de produits connexes. Ils offrent des services de bout en bout, y compris la préparation et la soumission de dossiers d'enregistrement, les évaluations de dangers/exposition/risques, la gestion des études, la gestion de la qualité et la représentation locale dans de nombreux pays grâce à une approche 'glocale' qui combine expertise globale et connaissance réglementaire locale.

Description

• Direct preparation, implementation, and coordination of regulatory projects for new product introductions and lifecycle maintenance across the U.S. Federal and State levels, and Canada and Mexico where applicable • Apply expert knowledge of FIFRA to register traditional actives, me-too products, biopesticides, and antimicrobial/biocide products • Navigate regulatory landscapes for biologicals, including biopesticides, biostimulants, and microbials • Perform comprehensive data gap analyses • Draft waiver requests and design testing strategies to meet EPA and state-level requirements • Draft and review regulatory labels, including biological product labels • Identify labeling issues and ensure compliance with federal and state labeling laws • Serve as the primary North American regulatory expert and point of contact for the knoell team • Educate the team on regulatory pathways, risks, and opportunities • Mentor and provide technical guidance to regulatory specialists and managers • Support long-term client relationships • Participate in initial client inquiry calls • Collaborate with sales teams on client proposals and quotes • Advise on budgets based on project scope and complexity • Provide competitive intelligence and insights on emerging regulatory trends • Collaborate with global colleagues to align North American strategies with international frameworks such as JMPR and EU frameworks

🎯 Exigences

• Bachelor’s degree required in Biology, Chemistry, Toxicology, Natural Resources, or a related scientific discipline • Minimum of 8+ years of professional experience in the registration of agrochemicals, crop nutrition, or related fields at the U.S. federal level • Proven track record of successfully registering products under FIFRA • Deep familiarity with regulatory strategy, data requirements, and risk assessment frameworks • Hands-on experience with traditional crop protection chemicals, biologicals (biopesticides/biofertilizers), and antimicrobials/biocides • Exceptional written and verbal communication skills in English • Ability to translate complex regulatory concepts for diverse audiences • Familiarity with Health Canada’s PMRA processes and JMPR evaluations preferred • Experience with topical animal health registrations or veterinary product regulations preferred • Understanding of state regulations, including California DPR and Florida DEP, and Section 24(c) filings preferred • Proficiency in German, Spanish, Portuguese, or Japanese is an asset

🏖️ Avantages

• Flexible working policy • Remote-first work options • Work from home, at headquarters in Mannheim, or at a local office based in your location • Part-time work options generally supported on request, subject to business requirements • Work-life balance support • Personal, leadership, and technical development opportunities • English language courses • Global employee referral program with rewards for referring talent • Opportunity to work with market leaders • Dynamic family-owned business environment with an international team • New ideas, creative approaches, and collaboration valued

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