Regulatory Affairs Consultant – CTA

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

📋 Description

• Collaborate with study teams to oversee the necessary regulatory activities, standards, and deliverables linked to the development and completion of CTA submissions.

• Lead and participate in pertinent meetings to promote realistic timelines for deliverables, comprehend project strategies, evaluate impacts, and present the status of global submission activities.

• Assist and spearhead global team initiatives to guarantee high-quality components and submissions that comply with industry standards, agency regulations, format guidelines, regulatory strategies, policies, and timelines.

• Oversee the assembly of core package builds, contributing to the creation of CTA and authoring documentation as necessary.

• Identify, inform, and resolve issues that could affect submission builds or the logistics of global submission delivery with regional and local partners or Health Authorities.

• Ensure that client work is executed and delivered punctually while adhering to business and client quality expectations.

• Act in a client-facing capacity with guidance and support from line management.

⛳️ Requirements

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

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

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

• A client-centered 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

• Training and insight into the organization’s fundamental consulting models and methodologies.

• Understanding of the services offered by Parexel.

• Assistance from senior staff to manage more complex tasks.

• Annual performance-based bonus plan for eligible positions.

• Annual salary review for eligible positions.

• Total rewards incentives for eligible positions.