Senior Regulatory Affairs Associate – CTA, MAA

Parexel

. Prepare, submit and maintain Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL) .

Posted 9/18/2026full-timeRemote • CzechiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Trial Applications (CTAs) and regulatory affairs, with a strong understanding of Czech and EU clinical trial legislation. Capable of managing lifecycle activities and ensuring compliance in product information maintenance while effectively communicating in an international environment.

Highest-signal resume keywords

Clinical Trial Applications (CTAs)Regulatory Affairs ExperienceLifecycle Management ActivitiesCzech/EU Clinical Trial LegislationEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Applications (CTAs)Regulatory SubmissionsLifecycle ManagementProduct Information MaintenanceRegulatory Strategy Implementation

Soft Skills

Strong Organizational SkillsAttention to DetailAbility to Manage Multiple ProjectsAbility to Work Independently

Certifications & Qualifications

University Degree in Life Science

Industry Keywords

Regulatory ContactRegulatory LeadPost-Authorisation ActivitiesAmendmentsNotifications

About the role

Key responsibilities & impact

Prepare, submit and maintain Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL)
Support CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities
Manage post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures
Review and update product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements
Coordinate with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions
Track regulatory commitments, maintain documentation and support regulatory strategy implementation
Work under the general direction of a Project Lead and/or Technical SME, ensuring client work is delivered on time and meets quality expectations
Potentially act in a client-facing role with guidance and support from line management

Requirements

What you’ll need

University degree in a life science discipline
Previous regulatory affairs experience in CTA and MAA activities within the EU
Good understanding of Czech/EU clinical trial and medicinal product legislation
Experience with lifecycle management activities (variations, transfers, renewals) and product information maintenance
Strong organizational skills, attention to detail and ability to manage multiple projects simultaneously
Effective communication skills and ability to work independently in an international environment
Fluent in English, written and spoken