Senior Regulatory Affairs Consultant – EU Regulatory Strategy, MAA

Parexel

. Lead and manage Marketing Authorisation Applications (MAAs) with strategic regulatory input on application pathways and dossier packages .

Posted 10/9/2026full-timeRemote • Romania, Croatia, Poland, Hungary, SerbiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong focus on Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements, ensuring compliance and strategic alignment with product development and commercial objectives.

Highest-signal resume keywords

Regulatory Affairs ExperienceMarketing Authorisation Applications (MAAs)European Medicines Agency (EMA) InteractionsRegulatory Strategy DevelopmentStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentDossier ReviewModule 1 Submission DocumentationRegulatory Documentation PreparationHealth Authority EngagementCritical Document ReviewPaediatric Development PlansScientific Advice PackagesCompetitive Regulatory IntelligenceRegulatory Maintenance

Soft Skills

Project LeadershipCommunication SkillsStakeholder ManagementInfluencing SkillsTime Management

Industry Keywords

Life Science DegreeEU Product DevelopmentRegulatory ProceduresHealth Authority QuestionsCross-Functional Collaboration

About the role

Key responsibilities & impact

Lead and manage Marketing Authorisation Applications (MAAs) with strategic regulatory input on application pathways and dossier packages
Develop and execute regulatory strategies aligned with product development timelines and commercial objectives
Conduct critical document reviews and provide competitive regulatory intelligence to support informed decision-making
Prepare core regulatory documents including briefing books, paediatric development plans, and scientific advice packages
Own Module 1 submission documentation and coordinate submission preparation activities
Manage responses to health authority questions and requests with timely, high-quality deliverables
Ensure timely execution of regulatory activities across assigned products and programmes
Lead pre-submission activities, scientific advice procedures, and post-approval regulatory maintenance with the European Medicines Agency (EMA)
Serve as key interface with health authorities and cross-functional stakeholders including Clinical, Medical, Safety, Quality, CMC, and Commercial functions
Influence senior stakeholders and navigate complex regulatory challenges in a consultancy environment

Requirements

What you’ll need

University degree in a Life Science discipline
Significant Regulatory Affairs experience supporting EU product development and lifecycle management
Proven experience leading or supporting EMA interactions and regulatory procedures
Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements
Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials
Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement
Excellent project leadership, stakeholder management, and communication skills
Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment
Fluent in English, written and spoken