CMC Regulatory Strategist

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $190 000 - $210 000 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

🚔 Conformité

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Rho

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 1984

💳 Fintech

🤝 B2B

🏦 Banque

Fintech • B2B • Banking

Rho est un CRO d'un nouveau genre, centré sur la connexion. Nous sommes une communauté d'esprits curieux et de résolveurs de problèmes qui croient que la recherche clinique repose sur une collaboration étroite avec tous les impliqués : sponsors, enquêteurs, sites et patients. Notre gamme complète de services de développement clinique et de domaines d'expertise spécialisée reflète notre engagement constant à faire partie de quelque chose de plus grand. Nous ne nous contentons pas de naviguer à travers les défis, nous prospérons en les affrontant, en tissant des liens plus forts. Rho offre une variété de services incluant la gestion de projets cliniques, la stratégie et les soumissions réglementaires, la biométrie et l'assurance qualité, en mettant l'accent sur la neurologie, la psychiatrie, les problèmes respiratoires et l'immunologie. Notre équipe expérimentée garantit que les essais cliniques sont efficaces et efficients en tirant parti des perspectives stratégiques et des relations solides dans le secteur de la santé.

Description

• On behalf of Rho’s clients, support and advise the CMC and related regulatory components of integrated development programs, including the review of technical documents, participation in technical discussions, and collaborations with CDMOs and other vendors. • Provide CMC regulatory-related leadership, guidance, and support to a team • Mentor and advise Rho staff in CMC regulatory strategy and product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members • Proactively identify risks and critically analyze problems affecting the programs and develop contingency plans as needed • Facilitate achievement of strategic goals for a program • Monitor ongoing progress of key CMC deliverables against Global Integrated Product Development Plan goals • Ensure effective, accurate and timely communication of key issues and progress to the team and senior management • Participate in the planning, preparation, and conduct of regulatory authority meetings; lead CMC discussions with regulatory authorities • Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers • Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; provide guidance and input to the budgets and business submissions of proposals

🎯 Exigences

• PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 12 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) is desired • Excellent regulatory intuition and project management acumen with an in-depth CMC regulatory and product development experience, and a firm understanding of the dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs across all phases from pre-phase 1 to marketing application. • Excellent communication skills (written, verbal, interpersonal, and presentation) and the ability to interact effectively with all levels both within and outside the company; proven ability to establish credibility with professionals on program teams; ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure • Ability to understand and motivate others and build effective teams• • Critical thinking skills with the ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self) • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments

🏖️ Avantages

• Medical • Vision • Dental • HSA • FSA • EAP • Life & disability insurance • 401(k) • Paid time off • Holidays • Parental leave • Bereavement leave • Work-life balance