Regulatory Affairs Consultant – Global Submission Coordinator, EU and US

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee the preparation, compilation, and submission of new drug applications as well as lifecycle management (LCM) activities.

• Work closely with Regional Submission Coordinators to guarantee the completeness of essential documentation needed for global and regional submission planning and requirements.

• Organize meetings for the submission team and promote effective communication among all stakeholders.

• Create necessary records in submission planning tools and Regulatory Information Management Systems.

• Develop Submission Content Plans (SCP) in accordance with country-specific regulatory requirements.

• Coordinate, request, and monitor documentation from relevant Subject Matter Experts (SMEs) to ensure timely and thorough submission readiness.

• Provide consistent updates to the submission team regarding status and timelines.

• Draft M1 documents as needed and facilitate their review process.

• Assist in the preparation of labeling, particularly in the Artwork management system and change control system.

⛳️ Requirements

• Bachelor's degree in a Life Sciences discipline.

• Experience in regulatory affairs within the pharmaceutical or biotechnology sectors.

• Proven experience in regulatory submission strategy and execution, ideally on a global scale.

• Strong knowledge of regulatory submission processes in Europe and the United States.

• Preferred experience with various international regulatory submission routes (e.g., ACCESS, reliance pathways).

• Exceptional project management and organizational capabilities.

• Strong skills in communication and stakeholder management.

• Proficient in regulatory tracking systems and the Microsoft Office Suite.

• Fluent in English, both written and spoken.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Flexible work arrangements.

• Opportunities for professional development.