Senior Regulatory Affairs Associate – Regional Submission Coordinator
Parexel
full-time
Posted on:
Location Type: Remote
Location: Romania
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Job Level
About the role
- Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities in alignment with submission strategy
- Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation
- Organize submission team meetings and facilitate effective communication among all stakeholders
- Open required records in submission planning tools and Regulatory Information Management Systems
- Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements
- 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
- Draft M1 documents as required and coordinate their review with LRR or RPR
- Support labeling preparation
- Upload M1 documents in archiving system
Requirements
- 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 and Microsoft Office Suite
- Fluent in English, written and spoken.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submission strategyregulatory submission processessubmission content plansM1 documents preparationlabeling preparationdocumentation trackingsubmission readinesslifecycle management activitiesinternational regulatory submission routesregulatory affairs
Soft Skills
project managementorganizational skillscommunication skillsstakeholder managementteam coordination