Regulatory Affairs Consultant – CTA

This is a fully remote position, open to applicants in Romania.

📋 Description

• Collaborates with study teams, overseeing the management of necessary regulatory activities, standards, and deliverables related to the development and completion of CTA submissions and associated documentation.

• Leads and participates in relevant meetings to advocate for realistic timelines, comprehend project strategies, evaluate the associated impact, and present the current status of global submission delivery activities.

• Supports and directs global team initiatives to ensure the production of high-quality components and submissions that comply with industry standards, agency guidelines, regulatory strategies, policies, and timelines.

• Manages the assembly of core package builds, contributing to CTA documentation and drafting as needed.

• Escalates, notifies, and resolves any issues that could affect submission builds or the logistics of global submission delivery to regional, local partners, or Health Authorities.

⛳️ Requirements

• A minimum of a Bachelor's Degree in a Scientific or Technical Discipline.

• Several years of experience in a CRO/Pharma setting.

• Experience with clinical trial submissions to the relevant Regulatory Authorities.

• A client-focused approach to work.

• Exceptional interpersonal and intercultural communication skills, both written and verbal.

• Strong critical thinking and problem-solving abilities.

• Proficiency in English and the local language (both written and spoken).

🏝️ Benefits

• A comprehensive benefits package designed to ensure your success and growth in this position.

• Training and insight into our organization's fundamental consulting models and methodologies.

• Support from our senior staff to help you successfully tackle more complex tasks.