[Remote] Regulatory Affairs Consultant - CTA

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company research and consulting organization offering regulatory affairs services. The Regulatory Affairs Consultant will manage and support reputed company Trial Application submissions, coordinate with study teams and reputed company, ensure compliant and reputed company deliverables, and reputed company issues affecting submission delivery.

Responsibilities

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required
• reputed company and attends relevant meetings to reputed company realistic deliverable timelines, understand project reputed company, and assess associated reputed company and present status of global submission delivery activities
• Support and leads global team efforts to ensure high reputed company components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
• Manages the compilation for reputed company package build, contributing to CTA and authoring documentation as required
• Escalates, informs, and resolves any issues that may reputed company submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities

Skills

• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
• A few years of experience in a CRO/reputed company
• Experience in reputed company trial submissions to the competent Regulatory Authorities
• reputed company-reputed company approach to work
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in English and local language (written and spoken)

Benefits

• Home- or office-reputed company work arrangement in Budapest
• Training and knowledge of the organization's basic consulting models and methodologies
• Understanding of the services reputed company offers
• Support from senior staff to accomplish more reputed company tasks successfully

reputed company

Company H1B Sponsorship