Regulatory Affairs Consultant (Global Submission Coordinator - EU and US)
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a highly organized and detail-oriented Regulatory Affairs Consultant to serve as a Global Submission Coordinator for EU and US markets. 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:
Global 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 Regional Submission Coordinators to ensure completeness of core documentation required to support global and 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
Experience in regulatory affairs within the pharmaceutical or biotechnology industry
Regulatory submission strategy and execution experience, ideally global
Strong understanding of regulatory submission processes in Europe and US
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 and Microsoft Office Suite
Fluent in English, written and spoken