Senior Regulatory Affairs Associate – Regional Submission Coordinator

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

📋 Description

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

• Collaborate closely with Global Submission Coordinators to guarantee the completeness of core documentation.

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

• Develop Submission Content Plans (SCP) tailored to specific regulatory requirements of each country.

• 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 necessary and manage their review process with LRR or RPR.

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

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

• Keep track of dispatched documentation for each country.

• Update Veeva as needed, which includes uploading each question received from Health Authorities into a record HAI.

⛳️ Requirements

• Bachelor’s degree in a Life Sciences discipline.

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

• Experience in regulatory submission strategy and execution, preferably on a global scale.

• Strong comprehension of regional regulatory submission processes.

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

• Exceptional project management and organizational capabilities.

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

• Fluency in English, both written and spoken.

🏝️ Benefits

• N/A