Senior Regulatory Affairs Consultant – EU Regulatory Strategy & MAA

We are seeking an experienced Regulatory Affairs Professional to provide strategic leadership and execution support across the full lifecycle of medicinal product development and registration within Europe. This role is ideally suited to a regulatory professional who combines deep EU regulatory expertise with strategic thinking, strong client-facing skills, and the ability to lead complex regulatory programmes from development through post-approval lifecycle management.

In this role, you will lead and manage Marketing Authorisation Applications (MAAs), providing strategic regulatory input on both the overall application pathway and the full dossier package. You will play a key role in the development and execution of regulatory strategies, conduct critical document reviews, and provide competitive regulatory intelligence to support informed decision-making and successful regulatory outcomes.

The successful candidate will actively contribute to regional and global regulatory activities, including leading the preparation of core regulatory documents such as briefing books, paediatric development plans, scientific advice packages, and other key regulatory deliverables. You will support investigational, new, and marketed product submissions while serving as a key interface with health authorities and cross-functional stakeholders.

The role can be home or office based in Poland, Croatia, Hungary, Romania or Serbia.

Key Responsibilities

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

Skills and Requirements

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