Senior Regulatory Affairs Associate – Regional Submission Coordinator

This is a fully remote position, open to applicants in Hungary, +4 more countries.

📋 Description

• Oversee the preparation, organization, and submission of new drug applications and lifecycle management tasks across designated regions.

• Collaborate with Global Submission Coordinators to guarantee the completeness of core documentation necessary for regional submission strategies.

• Arrange submission team meetings and enhance communication among CMC, labeling, regulatory leads, local regulatory representatives, and regulatory partner representatives.

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

• Develop Submission Content Plans tailored to specific country regulatory requirements and previous Health Authority feedback.

• Solicit and monitor documentation from subject matter experts to ensure timely and thorough submission preparedness.

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

• Draft M1 documents and coordinate their review process.

• Assist in the preparation of labeling within artwork management and change control systems.

• Upload M1 documents to the archiving system and finalize Submission Content Plans.

• Distribute and track non-eCTD regulatory packages to local and partner regulatory representatives.

• Upload submitted documentation to the archiving system for non-eCTD submissions.

• Update Veeva with inquiries from Health Authorities and other necessary information.

⛳️ Requirements

• Bachelor's degree in a Life Sciences field.

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

• Familiarity with regulatory submission strategy and execution, preferably on a global scale.

• Strong knowledge of regional regulatory submission processes.

• Experience with various international regulatory submission pathways, such as ACCESS and reliance routes, is preferred.

• Exceptional project management and organizational capabilities.

• Strong communication and stakeholder management skills.

• Proficient in regulatory tracking systems, including Veeva, as well as Microsoft Office Suite.

• Fluent in English, both written and spoken.

🏝️ Benefits

• Competitive salary and benefits package.

• Opportunities for professional development and growth.

• Collaborative and innovative work environment.

• Flexible working arrangements.