Senior Regulatory Affairs Associate, Small Molecules - Remote

Overview

The Senior Regulatory Affairs Associate plays a critical role in ensuring compliance with regulatory requirements for drug products, contributing to the preparation and delivery of regulatory submissions from a global perspective.

In Short

• Handle pre-approval (IND, NDA) and post-approval lifecycle management of drug products.
• Prepare and deliver regulatory maintenance submissions.
• Knowledge of EU and US regulatory procedures.
• Experience with CMC related health authority queries.
• Review Marketing Authorization Applications and Variations.
• Provide regulatory impact assessments for change proposals.
• Liaise with cross-functional team members.
• Maintain submission delivery plans and provide status updates.
• Experience in Regulatory Information Management Systems, particularly Veeva Vault.
• Strong communication skills and mentoring abilities.

Requirements

• 4-8 years of relevant experience in regulatory affairs.
• Good understanding of regulatory frameworks across various regions.
• Experience with documentation for various types of Variation procedures.
• Ability to work independently and within stipulated time periods.
• Strong organizational and project management skills.

Benefits

• Work with a global team dedicated to improving health.
• Opportunity to contribute to the development of therapies that benefit patients.
• Access to comprehensive drug development capabilities.
• Collaborative work environment.