Regulatory Affairs Manager - Remote

Overview

This position involves managing regulatory processes and preparing documentation for submissions to health authorities, ensuring compliance with global regulations.

In Short

• Manage regulatory documentation for health authority submissions.
• Plan and compile documents for INDs, NDAs, and other submissions.
• Provide regulatory direction to project teams.
• Maintain timelines for regulatory submissions.
• Review critical documents for compliance.
• Coordinate with vendors for submission planning.
• Maintain regulatory databases.
• Work independently on time-sensitive assignments.
• Communicate regulatory expectations to teams.
• Stay updated on global regulations and guidelines.

Requirements

• Bachelor’s degree in life sciences preferred.
• 8 years of experience in regulatory affairs.
• Experience with eCTD formatted submissions.
• Ability to lead responses to health authorities.
• Excellent communication and time management skills.

Benefits

• Patient Days for direct engagement with patients.
• A culture focused on patient-first values.
• Decentralized model for decision-making.
• Opportunities for career advancement.
• Access to learning and development resources.
• Market-competitive compensation and benefits.
• Flexible PTO.
• Commitment to Diversity, Equity & Inclusion.