Senior Regulatory Affairs Consultant – EU Regulatory Strategy, MAA

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

• Take the lead in overseeing Marketing Authorisation Applications (MAAs) by providing strategic regulatory insights on application pathways and dossier packages.

• Formulate and implement regulatory strategies that align with product development timelines and commercial goals.

• Perform thorough document reviews and supply competitive regulatory intelligence to aid in informed decision-making.

• Prepare essential regulatory documents, including briefing books, pediatric development plans, and scientific advice packages.

• Manage Module 1 submission documentation and coordinate all activities related to submission preparation.

• Handle responses to inquiries and requests from health authorities, ensuring timely and high-quality deliverables.

• Guarantee the timely execution of regulatory activities for assigned products and programs.

• Lead pre-submission efforts, scientific advice processes, and post-approval regulatory maintenance with the European Medicines Agency (EMA).

• Act as the primary liaison with health authorities and cross-functional stakeholders, including Clinical, Medical, Safety, Quality, CMC, and Commercial teams.

• Influence senior stakeholders and navigate complex regulatory challenges within a consultancy environment.

⛳️ Requirements

• Bachelor's degree in a Life Science field.

• Extensive experience in Regulatory Affairs, specifically in supporting EU product development and lifecycle management.

• Demonstrated experience leading or assisting with EMA interactions and regulatory procedures.

• Strong knowledge of Marketing Authorisation Applications (MAAs) and the requirements for CTD/eCTD dossiers.

• Experience in preparing and reviewing regulatory documentation, including Module 1 content and briefing materials for health authorities.

• Proven expertise in developing regulatory strategies, conducting dossier reviews, and engaging with health authorities.

• Exceptional project leadership, stakeholder management, and communication skills.

• Ability to manage multiple regulatory priorities while achieving high-quality results in a fast-paced setting.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to support work-life balance.