Senior Associate - Regulatory Affairs - Remote

Overview

The Senior Associate in Regulatory Affairs will assist in the creation and submission of regulatory documents and may lead regulatory programs under supervision, contributing to the mission of serving patients through innovative biotechnology.

In Short

• Assist in US regulatory activities including IND development and submission.
• Maintain IND/BLA documentation and regulatory history documents.
• Ensure compliance with regulatory submissions.
• Coordinate collection of functional documents for regulatory applications.
• Provide regulatory support to various departments.
• Participate in the implementation of regulatory strategies.
• Support process improvement initiatives and standards development.
• Prepare regulatory correspondence and packages.
• Engage in cross-functional interactions as needed.
• Actively support regulatory compliance and development.

Requirements

• Master’s degree or equivalent experience in Regulatory Affairs.
• Experience in regulated industry or clinical practice.
• Strong timeline management skills.
• Excellent oral and written communication skills.
• Organizational skills and ability to support ad hoc meetings.
• Ability to work collaboratively in a team environment.
• Experience with regulatory documentation and submissions.
• Knowledge of regulatory compliance processes.
• Proficiency in creating and maintaining documentation.
• Ability to adapt to changing regulatory environments.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models including remote work arrangements.
• Career development opportunities.