Senior Regulatory Affairs Associate

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

📋 Description

• Responsible for submitting labeling and safety variations across EU nations, including the UK and Ireland.

• In charge of preparing and reviewing M1 documents such as cover letters, eAF, mock-ups, clinical overviews, and literature references.

• Managed MRP and national procedures within the EU.

• Tasked with updating documents affected by labeling changes, including SmPC, PIL, and coordinating label artwork updates.

• Proficient in using Veeva to track submissions, update statuses, and create HAQs.

⛳️ Requirements

• Experience in submitting labeling and safety variations in EU countries, including the UK and Ireland.

• Skilled in the preparation and review of M1 documents such as cover letters, eAF, mock-ups, clinical overviews, and literature references.

• Familiarity with managing MRP and national procedures in the EU.

• Ability to update documents impacted by labeling changes, including SmPC, PIL, and/or coordinating label artwork updates.

• Experience with Veeva for tracking submissions, updating statuses, and creating HAQs.

🏝️ Benefits

• Comprehensive benefits package including health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.