Regulatory Affairs Consultant – CTA

Parexel

Regulatory Affairs Consultant responsible for managing regulatory submissions for clinical trials at Parexel. Collaborating with study teams and ensuring compliance with regulatory standards.

Posted 7/24/2026full-timeRemote • 🇷🇴 RomaniaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory activities and submissions for clinical trials, ensuring compliance with industry standards and guidelines. Strong communication and problem-solving skills are essential for effective collaboration with global teams and stakeholders.

Highest-signal resume keywords

Clinical Trial SubmissionsRegulatory ComplianceInterpersonal CommunicationCritical ThinkingProblem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Activities ManagementDocumentation AuthoringCore Package CompilationProject Strategy AssessmentSubmission Delivery Logistics

Soft Skills

Client-Focused ApproachIntercultural Communication

Industry Keywords

CROPharmaHealth AuthoritiesRegulatory AuthoritiesSubmission Guidelines

About the role

Key responsibilities & impact

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.
Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Requirements

What you’ll need

Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
A few years of experience in a CRO/Pharma
Experience in clinical trial submissions to the competent Regulatory Authorities
Client-focused 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

Comp & perks

Comprehensive benefits package to ensure your success and growth in this role.
Training and knowledge of our organization's basic consulting models and methodologies.
Support from our senior staff to accomplish more complex tasks successfully.