Senior Regulatory Affairs Associate (Regional Submission Coordinator)

Location: REMOTE, Romania, Remote, Budapest, Budapest, Hungary, Lithuania, Poland, Serbia

Employment Type: Remote

We are seeking a highly organized and detail-oriented Senior Regulatory Affairs Associate to serve as a Regional Submission Coordinator. This is a key operational role responsible for coordinating all activities required to deliver regulatory submissions across assigned regions, ensuring timely and compliant filings that support our clients drug development programs.

In this role, you will be at the heart of regulatory submission activities, working collaboratively with global teams, local regulatory representatives, and subject matter experts to ensure successful regulatory outcomes.

Key Responsibilities:

Regional Coordination & Stakeholder Management

• Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities in alignment with submission strategy as defined by the Regional Regulatory Lead (RRL) and submission team

• Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation required to support regional submission planning and requirements

• Organize submission team meetings and facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Representative (LRR), and Regulatory Partner Representative (RPR)

• Open required records in submission planning tools and Regulatory Information Management Systems

• Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements and prior Health Authority observations to ensure continuous improvement

• Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness

• Provide regular updates to the submission team on status and timelines

M1 Document & Labeling Support

• Draft M1 documents as required and coordinate their review with LRR or RPR

• Support labeling preparation, notably in Artwork management system and change control system

• Upload M1 documents in archiving system and complete the SCP accordingly

• Ensure dispatch of non-eCTD regulatory packages to LRR and RPR

• Track dispatched documentation for each country

• Ensure submitted documentation is uploaded to archiving system for non-eCTD submissions

• Update Veeva as required, including uploading each question received by Health Authorities in a record HAI

Skills & Experience required for the role:

• University degree in Life Sciences discipline

• 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry

• Regulatory submission strategy and execution experience, ideally global

• Strong understanding of regional regulatory submission processes

• Experience with different international regulatory submission routes preferred (e.g., ACCESS, reliance pathways)

• Excellent project management and organizational skills

• Strong communication and stakeholder management abilities

• Proficiency in regulatory tracking systems (Veeva) and Microsoft Office Suite

• Fluent in English, written and spoken

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